Novo Nordisk Inc Research Articles

Cost-effectiveness analysis of semaglutide 2.4 mg for the treatment of adult patients with overweight and obesity in the United States.

BACKGROUND: The rising prevalence and associated public health burden of obesity has led to advancements in pharmaceuticals for weight management. Semaglutide 2.4 mg, an anti-obesity medication (AOM) recently approved by the US Food and Drug Administration, has demonstrated clinically relevant weight loss in its phase 3 clinical trials. Economic evaluation comparing semaglutide 2.4 mg with other available weight management therapies is essential to inform payers for decision-making. OBJECTIVES: To assess the cost-effectiveness of semaglutide 2.4 mg in the treatment of adult patients with obesity (ie, body mass index [BMI] ≥ 30) and adult patients who are overweight (ie, BMI 27-29.9) with 1 or more weight-related comorbidities from a US third-party payer perspective. METHODS: A cohort Markov model was constructed to compare semaglutide 2.4 mg with the following comparators: no treatment, diet and exercise (D&E), and 3 branded AOMs (liraglutide 3 mg, phentermine-topiramate, and naltrexone-bupropion). All AOMs, including semaglutide 2.4 mg, were assumed to be taken in conjunction with D&E. Changes in BMI, blood pressure, cholesterol level, experience of acute and chronic obesity-related complications, costs, and quality-adjusted life years (QALYs) were simulated over 30 years based on pivotal trials of the AOMs and other relevant literature. Drug and health care prices reflect 2021 standardized values. Cost-effectiveness was examined with a willingness-to-pay (WTP) threshold of $150,000 per QALY gained. Sensitivity analyses were conducted to test the robustness of the cost-effectiveness results to plausible variation in model inputs. RESULTS: In the base-case analysis, treatment with semaglutide 2.4 mg was estimated to improve QALYs by 0.138 to 0.925 and incur higher costs by $3,254 to $25,086 over the 30-year time horizon vs comparators. Semaglutide 2.4 mg is cost-effective against all comparators at the prespecified WTP threshold, with the incremental cost per QALY gained ranging from $23,556 to $144,296 per QALY gained. In the sensitivity analysis, extended maximum treatment duration, types of subsequent treatment following therapy discontinuation, and weight-rebound rates were identified as key drivers for model results. The estimated probability of semaglutide 2.4 mg being cost-effective compared with comparators ranged from 67% to 100% when varying model parameters and assumptions. CONCLUSIONS: As a long-term weight management therapy, semaglutide 2.4 mg was estimated to be cost-effective compared with no treatment, D&E alone, and all other branded AOM comparators under a WTP threshold of $150,000 per QALY gained over a 30-year time horizon. DISCLOSURES: Financial support for this research was provided by Novo Nordisk Inc. The study sponsor was involved in several aspects of the research, including the study design, the interpretation of data, the writing of the manuscript, and the decision to submit the manuscript for publication. Dr Kim and Ms Ramasamy are employees of Novo Nordisk Inc. Ms Kumar and Dr Burudpakdee were employees of Novo Nordisk Inc at the time this study was conducted. Dr Sullivan received research support from Novo Nordisk Inc for this study. Drs Wang, Song, Wu, Ms Xie, and Ms Sun are employees of Analysis Group, Inc, who received consultancy fees from Novo Nordisk Inc in connection with this study.

752-P: Study Design and Baseline Profile for Patients with Type 2 Diabetes in the Semaglutide Once-Weekly Randomized Pragmatic Trial (SEPRA)

SEPRA (NCT03596450) is a 2-yr, multicenter, open-label, randomized pragmatic clinical trial comparing the long-term effects of once-weekly subcutaneous semaglutide vs. standard of care (both added to ≤2 oral antidiabetic medications) in US health-insured adults with T2D and physician-determined inadequate glycemic control. SEPRA will assess glycemic control, weight loss, healthcare utilization, and patient-reported outcomes by collecting individual-level data from routine clinical practice and health insurance claims. The primary endpoint is the proportion of patients achieving HbA1c <7.0% at yr 1. The study design was evaluated using the Pragmatic Explanatory Continuum Indicator Summary (PRECIS) -2 assessment; it scored 4-5 in all 9 domains, suggesting a highly pragmatic study. Of 1,278 patients enrolled, 54% were male with mean (± SD) age 57.4 ± 11.1 yrs, BMI 35.7± 8.0 kg/m2, diabetes duration 7.4 ± 6.0 yrs, HbA1c 8.48 ± 1.6%, and mean individualized HbA1c target 6.66 ± 0.5%. Of note, 86.9% of patients had HbA1c >7.0% and most required sizeable reductions in HbA1c to reach the clinician-assigned individualized target. SEPRA will provide real-world evidence on the long-term effectiveness of semaglutide in a population with a broad range of HbA1c levels and other clinical characteristics when used as intensification early on in usual T2D care practice settings. Disclosure V.Willey: Employee; HealthCore Inc. J.B.Buse: Consultant; Alkahest, Anji, AstraZeneca, Boehringer Ingelheim International GmbH, Cirius Therapeutics, Inc., Eli Lilly and Company, Fortress biotech, GentiBio, Glycadia, Glyscend, Janssen Pharmaceuticals, Inc., Mellitus Health, Moderna, Inc., Pendulum Therapeutics, Praetego, LLC, Stability Health, Valo, Zealand Pharma A/S, Other Relationship; Adocia, AstraZeneca, Eli Lilly and Company, Intarcia Therapeutics, Inc., MannKind Corporation, Novo Nordisk, Sanofi, Senseonics, vTv Therapeutics, Research Support; AstraZeneca, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, vTv Therapeutics, Stock/Shareholder; Glyscend, Mellitus Health, Pendulum Therapeutics, PhaseBio Pharmaceuticals, Inc., Praetego, LLC, Stability Health. B.Harty: None. J.L.Mitchell: None. B.P.Soule: Employee; Bristol-Myers Squibb Company, Novo Nordisk. H.N.Christensen: Employee; Novo Nordisk. M.J.Cziraky: None. S.Skibsted: Employee; Novo Nordisk. Funding Funded by Novo Nordisk Inc

Management of Type 1 Diabetes in Children in the Outpatient Setting.

Management of Type 1 Diabetes in Children in the Outpatient Setting.

Longitudinal Efficacy and Safety of N8-GP for Prophylaxis and Bleed Control in US Patients

Introduction: N8-GP is an extended half-life recombinant factor VIII product indicated for use in patients with hemophilia A. The pathfinder trials evaluated routine prophylaxis and bleed control in previously treated patients aged ≥12 years (pathfinder2) and patients aged <12 years (pathfinder5), including an extension trial (pathfinder8). The objective of the present analysis was to compare the efficacy and safety of N8-GP in US vs global (including US) patients.Methods: In the pathfinder2 trial, patients aged ≥12 years with severe hemophilia A were administered N8-GP 50 IU/kg every 4 days (Q4D) as routine prophylaxis or 20 to 70 IU/kg as on-demand treatment. Patients aged <12 years received prophylaxis with N8-GP 60 IU/kg twice weekly in the pathfinder5 trial, and bleeding episodes were treated with 20 to 75 IU/kg. In the pathfinder8 extension trial, the investigator decided on which treatment arm the patient should be allocated based on previous treatment regimen and taking into account bleeding tendency.Results: See Table for efficacy in prophylaxis (median annualized bleeding rates [ABRs]) and bleed treatment (success rate). Median ABRs tended to decrease from 0.84 (global) and 0.86 (US) in pathfinder2 to 0.00 (global) and 0.00 (US) in pathfinder8 in patients aged ≥12 years on the prophylaxis regimen. In addition, in patients aged <12 years, median ABRs decreased from 0.81 (global) and 0.76 (US) in pathfinder5 to 0.00 (global) and 0.49 (US) in pathfinder8. Treatment success rates for US patients were comparable to those for global patients across trials and 100% were rated “excellent” or “good” for patients aged <12 years in pathfinder8.Overall, there were 59 treatment-related adverse events (AEs) in patients on the prophylactic regimen in pathfinder2, 13 of which occurred in US patients, and 11 treatment-related AEs in patients treated on-demand, 3 of which occurred in US patients. In pathfinder5, there were 16 treatment-related AEs, 7 of which occurred in US patients. In pathfinder8, there were 6 treatment-related AEs in patients aged ≥12 years, 3 of which were in US patients. In addition, there was 1 treatment-related AE in a non-US patient aged <12 years. AEs included rash, redness, and injection site reactions. Across trials, 1 previously treated patient (an 18-year-old, from a US site) with an intron 22 inversion developed a low-titer inhibitor at 93 exposure days to N8-GP and was withdrawn when the titer progressed to >5 Bethesda units. The patient returned to their previous FVIII product, and their inhibitor status was negative at follow-up.Conclusions: Efficacy of N8-GP was sustained during the main and extension pathfinder trials in both global and US patients. In addition, a favorable safety profile was maintained throughout the course of the program. [Display omitted] DisclosuresWheeler: Novo Nordisk A/S: Consultancy; Bayer: Consultancy; BioMarin: Consultancy; HEMA Biologics: Consultancy; Spark: Consultancy; Takeda: Consultancy; UniQure: Consultancy. Kearney: Grifols: Research Funding; Daiichi Sankyo: Research Funding; CVS Pharmacy: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novo Nordisk Inc: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Bioverativ/Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Staber: Bayer, CSL Behring, Sanofi, Takeda: Membership on an entity's Board of Directors or advisory committees. Wufsus: Novo Nordisk Inc: Current Employment. Ostrow: Novo Nordisk Inc: Current Employment. Lentz: Novo Nordisk Inc: Consultancy, Honoraria, Research Funding.

Initial Clinical Presentation and Predictors of Thrombotic Thrombocytopenic Purpura in Quebec

Thrombotic microangiopathies (TMA) constitute a group of life-threatening diseases of different aetiologies characterized by similar symptoms. The compilation of comprehensive data related to the initial clinical presentation of TMA is challenging due to their rare occurrence.The objective of this study was to assess and determine the predictive value of the clinical presentation of patients with a suspected TMA episode, subsequently confirmed as thrombotic thrombocytopenic purpura (TTP), compared with non-TTP TMA by taking advantage of the centralized ADAMTS-13 testing in Quebec.All ADAMTS-13 activity and antibody titration were performed at CHU Saint-Justine (CHUSJ). Measurements and patient demographics (from April 2012 to December 2019) were extracted from the Laboratory Information System of the CHUSJ. Patients with presumed TMA were classified into TTP when ADAMTS-13 activity was ≤10%, or suspicion of TMA other than TTP (non-TTP TMA) when ADAMTS-13 activity was >10%. Clinical presentation was obtained through a survey form received with each plasma sample and containing information related to prior episodes of TMA, underlying conditions (pregnancy, cancer, infection, transplant, medication, other), clinical symptoms (fever, neurological signs, abdominal signs), and biological parameters (hemolytic anemia, thrombocytopenia). Statistical analyses were performed with IBM SPSS 26.0. The study was approved by the Research Ethics Committee of CHUSJ.A total of 2081 requests for ADAMTS13 testing were received during the study period, in 846 different individuals with suspected TMA: 147 patients (17%) had a confirmed TTP and 699 had a suspected non-TTP TMA. Clinical and biological characteristics associated with TMA suspicion were available for 105 TTP and 470 non-TTP TMA patients (68% of subjects).More than half of patients with TTP (55%; 48/87) had neurological signs at presentation compared to one third of patients (33%; 124/375) with non-TTP TMA (p=0.0001). There were no significant differences regarding fever and abdominal signs between the 2 groups (p=0.383 and p=0.355 respectively). Anemia and thrombocytopenia were reported in 92% (80/87) and 93% (86/92) of TTP patients compared to 74% (291/396) and 83% (352/426) of non-TTP TMA patients (p=0.0002 and p=0.009, respectively). Underlying conditions were reported in 62% (287/460) of non TTP-TMA patients compared to 35% (34/97) of TTP patients (p<0.0001). Kidney involvement was documented in 20% (91/460) of non-TTP TMA and 7% (7/98) of TTP (p=0.003). Transplantation tended to be more often reported in non-TTP TMA (11%;58/560 versus 4%;4/98 in TTP; p=0.079). Pregnancy or postpartum was found in 11% (29/267) of females with non-TTP TMA and 5% (3/57) of females with TTP (p=0.232). Infections were present in 15% (68/462) of non-TTP TMA and 14% (14/98) of TTP (p=0.912). Drug associated TMA was reported in 15% (70/461) of non-TTP TMA and 9 % (9/98) of TTP (p=0.123). Cancers were documented in 16% (74/462) of non-TTP TMA and 9% (9/98) of TTP (p=0.084).When addressing the odds of TPP according to the clinical presentation, patients with neurological signs were at higher risk to be diagnosed with TTP compared to those who did not have neurological signs (odds ratio, 2.52; IC95%, 1.51 to 4.20; p<0.001). Thirty percent of patients presenting with neurological signs had TTP compared to 14% presenting without neurological signs. Conversely, the risk to be diagnosed with TTP was lower in the setting of transplantation (odds ratio, 0.32; IC95%, 0.11 to 0.92; p=0.015). Indeed, among patients who have had a transplantation 7% were diagnosed with TTP, while 93% had non-TTP TMA. Finally, the risk of TPP was also lower in patients with TMA and concomitant kidney-related issue (OR=0.31; IC95%: 0.14 to 0.69; p=0.004) as among patients presenting with renal disorders, 93% were not subsequently diagnosed with TTP.In conclusion, the centralization of ADAMTS-13 activity testing in one reference center has enabled to determine the predictive value of clinical characteristics associated with TPP in comparison to other types of TMA for the entire province of Quebec, Canada. This study provides useful insight for caregivers and paves the way to the establishment of a provincial registry of TMA patients. [Display omitted] DisclosuresLapeyraque: Alexion Pharmaceuticals Inc: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Rivard: Bayer Inc: Membership on an entity's Board of Directors or advisory committees, Research Funding; Octapharma Inc: Membership on an entity's Board of Directors or advisory committees; Pfizer Inc: Membership on an entity's Board of Directors or advisory committees, Research Funding; CSL Behring Inc.: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novo Nordisk Inc: Membership on an entity's Board of Directors or advisory committees. Bonnefoy: Alexion Pharmaceuticals Inc: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi Genzyme Inc: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; CSL Behring Inc: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees.

Incidence of Thrombotic Microangiopathies in Quebec: An 8-Year Overview from a Laboratory Centralizing Adamts-13 Testing

Primary and secondary thrombotic microangiopathies (TMA) constitute a group of life-threatening diseases of different aetiologies characterized by similar symptoms. The comprehensive compilation of data related to TMA is challenging due to their rare occurrence. The objective of this study was to provide an overview of the incidence of thrombotic thrombocytopenia (TTP) and non-TTP TMAs in the Province of Quebec (PQ) (8.485 Million inhabitants in 2019) by taking advantage of the centralized ADAMTS-13 activity and antibody testing for PQ since 2013 at the CHU Sainte-Justine (CHUSJ)All ADAMTS-13 activity and antibody titration were performed locally at CHUSJ. ADAMTS-13 results and patient demographic characteristics from April 2012 to December 2019 were extracted from the Laboratory Information System of CHUSJ and used in an anonymized database. Information on previous TMA episodes was obtained from a standardized clinical assessment form accompanying each plasma sample. Statistical analyses were performed with IBM SPSS version 26.0. The annual incidence rates were calculated based on the number of patients with a first-time recorded diagnosis of TMA using the Quebec mid-year (yr) estimated population of the years at stake. Patients with suspected TMA were further divided into two categories: individuals with TTP, defined by either an ADAMTS-13 activity ≤10% or a positive anti-ADAMTS-13 antibody titration, and patients with a suspected TMA other than TTP (non-TTP TMA) with a result of ADAMTS-13 activity >10%. The study was approved by the Research Ethics Committee of CHUSJ.A progressive increase in the annual requests for ADAMTS13 activity was observed over the study period. The number of new patients increased from 2012 to 2016 but plateaued after 2016 at an average number of 170 new patients per year. The number of confirmed TTP cases in Quebec was higher from 2014 to 2018 compared to in 2012, 2013 and 2019 (Figure 1). A total of 2081 requests for ADAMTS13 activity testing were received during the study period, representing 846 subjects with a suspected TMA. 147 subjects (17%) had a confirmed TTP and 699 (83%) had a suspected non-TTP TMA.TMAs were suspected more often in females (59%), both in confirmed TTP (62%) and non-TTP TMA (58%).The mean annual incidence rate (MAIR) of TTP was 1.91 case/million/yr (95%CI: 1.46-2.35). This was higher in females (2.36 cases/million/yr; 95%CI: 1.34-3.37) compared to males (1.42 case/million/yr; 95%CI: 0.57-1.44; p=0.001). The MAIR of non-TTP TMA was 9.97 cases/million/yr (95%CI:5.85-14.09), 11.52 for females (95%CI:6.71-16.33) versus 8.41 for males (95% CI: 4.81-12.02; p=0.001).In non-TPP TMA, the MAIR for males ranged from 3.9 to 7.2 cases per million prior to 60 year of age and increased after up to 24.5 at ages 80-89. For females, a first peak MAIR above 10 cases per million was observed during their thirties and a second peak was observed during their seventies (Figure 2).In TPP, peaks incidences in females were observed from ages 20 to 49. It dipped from ages 50 to 69 and then increased again. In males, a highest MAIR was observed between ages 40 to 79.In conclusion, the provincial centralization of ADAMTS-13 testing has enabled us to depict comprehensive picture of TTP and other suspected non-TPP TMA, thereby providing valuable information for caregivers and health authorities into these rare diseases. Sex and age related incidences observed in this study are comparable to those obtained through other registries and aggregated studies. Further analyses on clinical presentation of TMAs and patient follow up are now possible using the identification of this large cohort. [Display omitted] DisclosuresLapeyraque: Alexion Pharmaceuticals Inc: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Rivard: Bayer Inc: Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer Inc: Membership on an entity's Board of Directors or advisory committees, Research Funding; Octapharma Inc: Membership on an entity's Board of Directors or advisory committees; Novo Nordisk Inc: Membership on an entity's Board of Directors or advisory committees; CSL Behring Inc.: Membership on an entity's Board of Directors or advisory committees, Research Funding. Bonnefoy: Sanofi Genzyme Inc: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; CSL Behring Inc: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Alexion Pharmaceuticals Inc: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

86-LB: Real-World Effectiveness of Oral Semaglutide (OS) from a U.S. Commercially Insured and Medicare Advantage Population

Background: With OS’s FDA approval in September 2019, this study sought to provide real-world evidence on its effectiveness in a cohort of early users. Methods: Claims and lab result data were used to identify T2D patients who initiated OS between 09/20/19 - 10/31/20 (first claim date set as index). Selected patients had ≥1 HbA1c result within both ≤3 months pre- and ≥3 months post-index and ≥ 12 months pre-index health plan eligibility. Study groups included: all patients, patients persistent on OS (those with a OS prescription within 1.5 times of days supply dispensed overlapping/in proximity to most recent post-index HbA1c), GLP-1 naive patients, and patients with a pre-index HbA1c >9%. Results: Of the 323 individuals with T2D initiating OS, 42.4% were female with a mean age of 55 years and 77% were GLP-1 naive. Mean HbA1c was significantly reduced in all patients (-0.9%) and subgroups (all p Conclusions: OS initiation was associated with a significant reduction in HbA1c and increase in HbA1c goal attainment in real-world practice in this preliminary cohort. Disclosure N. Shivappa: Other Relationship; Self; Novo Nordisk. C. Swift: Employee; Self; Novo Nordisk Inc. J. Noone: Employee; Self; Novo Nordisk Inc. S. Du: None. M. Radin: Employee; Self; Novo Nordisk Inc. C. Gamble: Employee; Self; Novo Nordisk Inc. H. Tan: Other Relationship; Self; HealthCore. V. Willey: Employee; Self; HealthCore.

683-P: Real-World Evaluation of Once-Weekly Semaglutide (Sema OW) in Patients Newly Initiating GLP-1 Agonist Therapy

Background: This study presents real-world effectiveness of sema OW in a cohort of US commercially insured/Medicare Advantage T2D patients newly initiating a GLP-1 agonist. Methods: Claims and lab result data were used to identify T2D patients who initiated sema OW between 12/1/17 - 6/30/20 (index as first claim). Selected patients had ≥1 A1c result within ≤3 months pre- and ≥3 months post-index. Patients with no claim for any GLP-1 agonist in the 12 months prior to index and persistent on sema OW (those with a sema OW prescription with days supply dispensed overlapping/in proximity of date of post-index A1c) were assessed for A1c changes and stratified by age ( 9%. Results: Of 1,842 patients newly initiating sema OW, 49% were female and 8% were ≥ 65 years of age. The pre/post change in A1c was significant in all patients (-1.3%) and in each age subgroup ( 9%, regardless of age. Attainment of A1c Conclusion: nitiation of sema OW in T2D patients naive to GLP-1 agonists and persistent on sema OW was associated with a significant reduction in A1c and an increase in target attainment of A1c Disclosure N. Shivappa: Other Relationship; Self; Novo Nordisk. C. Swift: Employee; Self; Novo Nordisk Inc. J. Noone: Employee; Self; Novo Nordisk Inc. S. Du: None. Y. M. Paprocki: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. H. Tan: Other Relationship; Self; HealthCore. V. Willey: Employee; Self; HealthCore.

653-P: Evaluating Antidiabetic Medication Treatment Patterns in T2D Patients Initiating Once-Weekly Semaglutide (sema OW)

Antidiabetic medication (med) treatment patterns often differ based on a variety of patient and prescriber factors. Understanding these patterns may provide insight on optimizing therapy, especially when considering initiation of a new therapy. This study presents real-world evidence on T2D treatment patterns associated with sema OW initiation within a large cohort of T2D patients. Methods: Claims and lab result data were used to identify T2D patients from a US commercially insured/Medicare Advantage population who initiated sema OW between 12/1/17 - 6/30/20 (index as 1st claim). Selected patients had continuous health plan enrollment for ≥ 2 years pre-index and post-index through at least 90 days after the last available A1c value. Antidiabetic meds prescribed before, at the time and after initiation of sema OW were evaluated overall and for those with an A1c &amp;gt;9%. Results: A total of 3,081 T2D patients were identified, of which 865 patients had A1c &amp;gt;9%. Sema OW was initiated down the treatment pathway, with ~60% on ≥2 and ~30% on 3+ T2D meds at sema OW initiation. Sema OW was an add-on therapy to most T2D med classes overall, although when initiated onto more complex therapy regimens it was more likely to be a therapy switch (T2D monotherapy = 24% switched to sema OW, dual therapy = 46%, triple therapy = 64%, 4+ T2D medications = 70%). Following post-index A1c measurement, 35% of patients overall and 29% with a baseline A1c &amp;gt;9% decreased the number of their T2D meds. Conclusion: Sema OW appeared to be initiated as add-on therapy, except for those on more complex regimens. Approximately 1/3 of patients decreased their overall T2D med use after evaluation of A1c following sema OW initiation. Further research is warranted to assess impact of initiating sema OW earlier in the T2D treatment pathway, especially in patients with cardiovascular and chronic kidney disease. Disclosure V. Willey: Employee; Self; HealthCore. N. Shivappa: Other Relationship; Self; Novo Nordisk. C. Swift: Employee; Self; Novo Nordisk Inc. J. Noone: Employee; Self; Novo Nordisk Inc. S. Du: None. Y. M. Paprocki: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. H. Tan: Other Relationship; Self; HealthCore.

1271-PUB: Real-World Effectiveness of Newly Initiated Once-Weekly Semaglutide (sema OW) by Prescriber Specialty

Background: Both primary care physicians (PCPs) and endocrinologists (Endos) commonly prescribe T2D medications. This study presents real-world effectiveness of sema OW by prescriber specialty in a cohort of US commercially insured/Medicare Advantage T2D patients newly initiating a GLP-1 agonist. Methods: Claims and lab result data were used to identify T2D patients who initiated sema OW between 12/1/17 - 6/30/20 (index as first claim). Selected patients had ≥1 A1c result within ≤3 months pre and ≥3 months post-index. Patients with no claim for any GLP-1 agonist in the 12 months pre-index and persistent on sema OW (those with a sema OW prescription with days supply dispensed overlapping/in proximity of date of post-index A1c) were assessed for A1c changes stratified by prescriber specialty (PCPs/Endos) and by pre-index A1c >9%. Results: A1c was significantly reduced vs. pre-index in 1,284 patients prescribed sema OW by a PCP or Endo (both -1.3%; p 9% (both -2.8%; p Conclusion: Similar pre/post reductions in A1c were observed when initiating sema OW in T2D GLP-1 agonist naive patients being treated by PCPs and Endos. Disclosure N. Shivappa: Other Relationship; Self; Novo Nordisk. J. Noone: Employee; Self; Novo Nordisk Inc. C. Swift: Employee; Self; Novo Nordisk Inc. S. Du: None. H. Tan: Other Relationship; Self; HealthCore. Y. M. Paprocki: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. V. Willey: Employee; Self; HealthCore.

652-P: Real-World Effectiveness of Once-Weekly Semaglutide (sema OW) from a U.S. Commercially Insured and Medicare Advantage Population

Background: This study presents real-world evidence on effectiveness of sema OW in a broad cohort of US commercially insured and Medicare Advantage T2D patients. Methods: Claims and lab result data were used to identify T2D patients who initiated sema OW between 12/1/17 - 6/30/20 (index as first claim). Selected patients had ≥1 A1c result within ≤3 months pre- and ≥3 months post-index. Patients persistent on sema OW (those with a sema OW prescription with days supply dispensed overlapping/in proximity of date of post-index A1c measurement) were assessed for A1c changes and stratified by age ( 9%. Results: 3,010 patients initiated sema OW, 49% were female and 10% were ≥ 65 years of age. A1c was significantly reduced vs. pre-index in all persistent patients (-1.1%) and in each age subgroup ( 9%. Attainment of A1c Conclusion: In this broad, real-world cohort of US T2D patients, initiation of sema OW was associated with significant reduction in A1c and an increase in reaching an A1c Disclosure V. Willey: Employee; Self; HealthCore. N. Shivappa: Other Relationship; Self; Novo Nordisk. J. Noone: Employee; Self; Novo Nordisk Inc. C. Swift: Employee; Self; Novo Nordisk Inc. S. Du: None. Y. M. Paprocki: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. H. Tan: Other Relationship; Self; HealthCore.

84-OR: Semaglutide 2.4 mg Improves Health-Related Quality of Life in Adults with Overweight/Obesity and Type 2 Diabetes in the STEP 2 Trial

Effects of s.c. semaglutide 2.4 mg vs. placebo on health-related quality of life (HRQoL) were evaluated in the STEP 2 trial in adults with overweight/obesity and T2D. The STEP 2 trial was an RCT in adults with BMI ≥27 kg/m2 and T2D (NCT03552757). Patients were randomized 1:1:1 to 68 weeks’ once-weekly semaglutide 2.4 mg (N=404), 1.0 mg (N=403; results not shown), or placebo (N=403), plus lifestyle intervention. Changes in scores at week 68, and achievement of clinically meaningful within-person improvements (see Table for meaningful change thresholds), in weight-related QoL (Impact of Weight on Quality of Life-Lite Clinical Trials Version [IWQoL-Lite-CT]) and HRQoL (SF-36v2® Health Survey acute version [SF-36]) were assessed. Body weight change at week 68 with semaglutide 2.4 mg vs. placebo was -9.6% vs. -3.4%. Changes in IWQoL-Lite-CT scores and SF-36 scores (except role-emotional) were consistently in favor of semaglutide vs. placebo (Table). The proportions of patients with clinically meaningful improvements was greater with semaglutide vs. placebo for all IWQoL-Lite-CT scores and SF-36 physical functioning score (Table). In adults with overweight/obesity and T2D, semaglutide 2.4 mg improved both physical and mental health components vs. placebo and led to greater proportions of patients with clinically meaningful changes in weight-related QoL and physical functioning. Disclosure D. Rubino: Advisory Panel; Self; Novo Nordisk, Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk, Speaker’s Bureau; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. L. Faerch: Employee; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Novo Nordisk A/S. H. H. Meincke: Employee; Self; Novo Nordisk A/S. R. F. Kushner: Advisory Panel; Self; Novo Nordisk A/S. S. Pedersen: Advisory Panel; Self; AstraZeneca, Bausch and Lomb Incorporated, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, HLS Therapeutics Inc., Janssen Global Services, LLC., Novo Nordisk, Consultant; Self; Abbott, Research Support; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk, Pfizer Inc., Speaker’s Bureau; Self; Abbott Laboratories, AstraZeneca, Bausch and Lomb Incorporated, Bayer Inc., Boehringer Ingelheim (Canada) Ltd., Dexcom, Inc., Eli Lilly and Company, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk, Sanofi. D. H. Ryan: Advisory Panel; Self; Alyvent, Naturally Slim, Epitommee,, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Global Services, LLC., Pfizer Inc., Redesign Health, Inc., Sanofi, Consultant; Self; Bausch Health, Canada, Phenomix, Xeno Bioscience, Gila Therapeutics, Scientific Intake, UnitedHealth Group, Other Relationship; Self; Novo Nordisk Inc. S. Wharton: Advisory Panel; Self; Novo Nordisk A/S, Novo Nordisk Canada Inc., Speaker’s Bureau; Self; AstraZeneca, Bausch Health, Canada, Novo Nordisk, Novo Nordisk Canada Inc. N. Zeuthen: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. R. Kolotkin: Consultant; Self; Novo Nordisk, Other Relationship; Self; Rhythm Pharmaceuticals, Inc. Funding Novo Nordisk A/S

414-P: Apparent Diffusion Coefficient on Diffusion-Weighted Magnetic Resonance Imaging Predicts the Progression of Renal Damage in Diabetic Nephropathy

Renal damage in diabetic nephropathy (DN) is evaluated by biochemical tests such as urine albumin-to-creatinine ratio (UACR) and serum estimated glomerular filtration rate (eGFR). On the other hand, renal biopsy, which is rich in definitive information, is rarely performed because of its complexity and high invasion. To evaluate whether diffusion-weighted magnetic resonance imaging (DW-MRI) could be a noninvasive approach for distinguishing DN, we performed MRI scanning of the subjects with 6 b-values (b = 0, 50, 100, 350, 400, 700) and analyzed the parameters using the kidney imaging software (Hitachi, Ltd., Tokyo). A total of 40 subjects were enrolled, 25 of whom had type 2 diabetes with or without hypertension (T2D), 9 had nondiabetes but hypertension (HT), and 6 were healthy volunteers (Control). T2D showed lower values of apparent diffusion coefficient (ADC) 0-700 compared with HT (129.0 ± 2.12 x10-5mm2/s in T2D vs. 132.5 ± 1.43 ×10-5mm2/s in HT, p&amp;lt;0.001). In addition, T2D with HT (n=15) had lower ADC0-700 compared with T2D without HT (n=10) (p &amp;lt; 0.01). Interestingly, T2D with non-DN nor HT presented lower ADC0-700 compared with HT (p&amp;lt;0.05). ADC0-700 in T2D were correlated with serum eGFR (r = 0.40, p &amp;lt;0.05) and inversely correlated with serum creatinine (r = - 0.40, p &amp;lt;0.05), cystatin C (r = - 0.54, p &amp;lt;0.01) and UACR (r = - 0.57, p &amp;lt;0.01). On the other hand, ADC0-700 in HT were not correlated with any of parameters of the renal function. Multivariate regression analysis with a stepwise forward method identified UACR as the only factor associated with the ADC0-700 values (β = - 0.68, p &amp;lt;0.001). Accumulating evidences show that lower levels of ADC on DW-MRI indicate greater fibrosis in various organs. Therefore, cortical ADC0-700 could predict the progression of the renal damage such as tubulointerstitial fibrosis. DW-MRI might provide a convenient diagnostic tool in the evaluation of DN. Disclosure H. Kitsunai: None. Y. Takiyama: Other Relationship; Self; Gilead Sciences, Inc., Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Mochida Pharmaceutical Co., Ltd., Roche Diabetes Care, Taisho Pharmaceutical Co., Ltd. N. Nakagawa: None. N. Hasebe: None. A. Okizaki: Research Support; Self; Fuji-Film Toyama Chemical Co., Ltd., Nihon Medhi-physics. M. Haneda: Advisory Panel; Self; Eli Lilly Japan K. K., Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk Inc. Funding Japan Society for the Promotion of Science (20K17420)

101-LB: Reported Satisfaction during the Medtronic Extended-Wear Infusion Set (EWIS) Pivotal Trial

Objective: Most insulin infusion sets (ISs) are labeled for 2- or 3-days use. The Medtronic EWIS is designed to increase wear time up to 7 days, and demonstrated a 74.8% survival rate (77.8%, excluding inadvertent early removal) in the pivotal trial (ClinicalTrials.gov: NCT04113694). This study reports on study participant satisfaction during the EWIS pivotal trial.Method: This multi-center (15), single-arm, non-randomized, non-inferiority trial in 259 participants (18-80yrs) with T1D using the MiniMed™ 670G system (with Humalog™ or Novolog™ insulin) involved wearing a 2- or 3-day IS for 2 weeks (run-in) followed by 12 consecutive EWIS wears (study phase). The latter was worn for ≥174 hours or until set failure. Participants completed a Medtronic Likert-based questionnaire at baseline and study exit. The averaged paired change in score at study-baseline was determined (Wilcoxon signed-rank test).Result: Reported satisfaction data during 2- or 3-day IS versus EWIS wear (Figure) show that ease and convenience of use, comfort, wear duration and time required to change a set were significantly improved with EWIS (p<0.001).Conclusion: These findings point to significantly greater satisfaction with the EWIS when compared with a 2- or 3-day IS, which may result in reduced care burden and improved adherence.View largeDownload slideView largeDownload slide DisclosureR. L. Brazg: Research Support; Self; Abbott Diabetes, Ascensia Diabetes Care, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Pfizer Inc., Roche Diagnostic USA, Senseonics. B. Horowitz: Research Support; Self; Abbott Laboratories, BD, Celgene, Crinetics Pharmaceuticals, Gan & Lee Pharmaceuticals, Medtronic, Speaker’s Bureau; Self; AstraZeneca, Lilly Diabetes, Merck & Co., Inc., Novo Nordisk Inc. K. B. Kaiserman: Advisory Panel; Self; Medtronic, Consultant; Self; Medtronic, Employee; Self; MannKind Corporation, Research Support; Self; Medtronic, Speaker’s Bureau; Self; Medtronic, Stock/Shareholder; Self; MannKind Corporation. S. Huang: None. V. Chen: Employee; Self; Medtronic. G. Zhang: Employee; Self; Medtronic. S. Chattaraj: Employee; Self; Medtronic. J. Shin: Employee; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic. T. S. Bailey: Consultant; Self; Abbott Diabetes, LifeScan, Novo Nordisk, Sanofi, Research Support; Self; Abbott, Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Livongo, Medtronic, Medtrum Technologies, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker’s Bureau; Self; BD, Medtronic, Sanofi. Y. C. Kudva: Research Support; Self; Dexcom, Inc. S. K. Garg: Advisory Panel; Self; Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. G. Grunberger: Research Support; Self; Medtronic, Speaker’s Bureau; Self; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk. A. Cavale: Research Support; Self; Eli Lilly and Company, Medtronic. J. Thrasher: Advisory Panel; Self; Medtronic, Board Member; Self; Medtronic, Consultant; Self; Medtronic, Research Support; Self; Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Mylan N. V., Novo Nordisk, Sanofi, Speaker’s Bureau; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Medtronic, Sanofi. A. Bhargava: Research Support; Self; Abbott, AbbVie Inc., Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Boston Therapeutics, Inc., Covance Inc., Dexcom, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Insulet Corporation, Janssen Research & Development, LLC, Kowa Pharmaceuticals America, Inc., Madrigal Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Mylan N. V., Novo Nordisk, Poxel SA, Quintiles, Sanofi, Senseonics, Tolerion, Inc., Viking Therapeutics. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care.

493-P: Do Spanish Language Pictograms Reflect Objective Physical Activity Data in Hispanics/Latinos with or at Risk of Type 2 Diabetes?

Assessing physical activity (PA) in Hispanics/Latinos with/at risk of type 2 diabetes (T2D) may be challenging due to language, health literacy, and cultural barriers. We compared self-reported PA using Spanish-language pictograms (SP) with objectively assessed PA data in Hispanic/Latino adults with low education, with or at risk of T2D.Subjects [n=102, 67 women, 88 T2D, age 58.2±10.3 years, BMI 31.3±5.7, HbA1c% 7.9±2.0, (mean±SD), and approximately 50% have less than high school education] wore an Actigraph (AG) on the dominant hip to objectively monitor PA (steps) for 7 days stratified by time (6am-12pm, 12pm-6pm, 6pm-12am) and subjectively assessed PA, using SP, (stratified as sleep, sedentary rest and work, housework, manual work, and exercise) and 10-point Likert scale (1 “not active” to 10 “very, very active”). Subjects worked 5 (0-7) [median (range)] days with 3 also working (sedentary) at weekends. Most participants were asleep 12am - 6am, and 3 worked nights.Subjects self-perceived as very active (7.4±2.1 Likert score) at work. Barring exercise, objectively measured PA increased with SP-reported PA.Spanish language pictograms to measure PA may have value in physical activity monitoring in Hispanics/Latinos with low education and with or at risk of T2D.View largeDownload slideView largeDownload slide DisclosureD. Haj: None. W. C. Bevier: Research Support; Self; Abbott Diabetes, Eli Lilly and Company. A. J. Larez: Research Support; Self; Abbott, Eli Lilly and Company. C. Conneely: Research Support; Self; Abbott, Eli Lilly and Company. N. M. Glantz: Research Support; Self; Abbott, Eli Lilly and Company. K. N. Castorino: Consultant; Self; Dexcom, Inc., Research Support; Self; Abbott Diabetes, Abbott Laboratories, Dexcom, Inc., Drawbridge Health, Inc., Lilly Diabetes, Medtronic, Novo Nordisk Inc. D. Kerr: Advisory Panel; Self; Novo Nordisk, Sanofi-Aventis, Research Support; Self; Abbott Diabetes, Elsevier, Lilly Diabetes, Stock/Shareholder; Self; Glooko, Inc.FundingEli Lilly and Company

497-P: Weekdays or Weekends? Does Timing of Physical Activity Assessment Matter in Hispanic/Latino Adults with or at Risk for Type 2 Diabetes?

Increasing physical activity (PA) in minority populations with type 2 diabetes (T2D) is likely to have important cardiometabolic benefits. The aim of this study is to determine feasibility and acceptability of using wearable accelerometers to assess PA, as part of creating a unique, real-world dataset on health determinants, in Hispanic/Latino adults with or at risk for T2D. PA was measured using an ActiGraph wGT3X-BT worn on the right hip 24 hours/day for 7 consecutive days. Insulin resistance (HOMA IR) and Metabolic Syndrome Score (MetS z) were calculated in 157 Hispanic/Latino participants [107 women, (mean ±SD) age 56.7 ± 11.0 years, (median [IQR]) HbA1c 7.6 [6.5, 9.4] %]. For those diagnosed with T2D, n=133, duration of diabetes was 13.2±9.0 years. There were significant correlations between Weekday steps and age (-0.31), waist circumference (WC) (-0.30), and BMI (-0.22) (p In conclusion, PA during Weekdays is higher than Weekends for Hispanic/Latino adults with or at risk for T2D. Weekday steps were also associated with a smaller WC and thus lower cardiometabolic risk. In this population, women were significantly more obese and insulin resistant than men. Disclosure W. C. Bevier: Research Support; Self; Abbott Diabetes, Eli Lilly and Company. A. J. Larez: Research Support; Self; Abbott, Eli Lilly and Company. C. Conneely: Research Support; Self; Abbott, Eli Lilly and Company. N. M. Glantz: Research Support; Self; Abbott, Eli Lilly and Company. K. N. Castorino: Consultant; Self; Dexcom, Inc., Research Support; Self; Abbott Diabetes, Abbott Laboratories, Dexcom, Inc., Drawbridge Health, Inc., Lilly Diabetes, Medtronic, Novo Nordisk Inc. D. Kerr: Advisory Panel; Self; Novo Nordisk, Sanofi-Aventis, Research Support; Self; Abbott Diabetes, Elsevier, Lilly Diabetes, Stock/Shareholder; Self; Glooko, Inc. Funding Eli Lilly and Company

750-P: Afinion HbA1c Dx Point-of-Care Test Is Accurate to Diagnose Diabetes in CLIA-Waived Settings

No point of care HbA1c (A1c) assays are CLIA waived for use in diagnosing diabetes. The accuracy of the Abbott Afinion HbA1c Dx (Afinion) was evaluated for this purpose. Operators with no laboratory training (N=21) tested fingerstick (FS) and venous (V) whole blood samples from subjects at 7 CLIA waived sites with 2 Afinion analyzer models (AS100 and Afinion 2). Operators self-trained on use of the Afinion using only materials that are provided when the test is purchased. A portion of each subject’s V sample was tested with a recognized comparative method (CM) at an NGSP Secondary Reference Laboratory (SRL). Consistent with FDA requirements for total error of A1c test systems, the percentage of Afinion results within an Allowable Total Error (ATE) zone of ±6% of the CM result was calculated, as well as the bias at 6.5% A1c. A total of 1,229 subjects with A1c values spanning the Afinion assay measuring range were enrolled. For the Afinion 2, 95.04% (95% lower confidence limit, LCL: 93.33%) of FS and 94.86% (95% LCL: 93.12%) of V results were within the ATE zone. For the AS100, 94.22% (95% LCL: 92.38%) and 93.36% (95% LCL: 91.41%) of Afinion results were within the ATE zone for FS and V samples, respectively. The bias at 6.5% A1c for the Afinion 2 was -0.13% (-0.008% A1c units) for FS and 0.01% (0.000% A1c units) for V samples. For the AS100, the bias was 0.62% (0.040% A1c units) and 1.13% (0.073% A1c units) for FS and V samples, respectively. No operator effects and no differences between the Afinion and CM results that could potentially impact clinical decision making were observed in this study. In subjects with unreported hemoglobin variants (detected by CM), 16/16 FS and 15/16 V Afinion results were within the ATE zone when compared to a second NGSP certified method at the same SRL. These data support the use of Afinion in CLIA waived settings to diagnose diabetes. Disclosure M. Clendenin: Employee; Self; Abbott. A. J. Nation: None. R. C. San george: Other Relationship; Self; Abbott. K. Kupfer: Employee; Self; Abbott. K. S. Fortner: Employee; Self; Abbott. R. R. Little: None. T. S. Bailey: Consultant; Self; Abbott Diabetes, LifeScan, Novo Nordisk, Sanofi, Research Support; Self; Abbott, Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Livongo, Medtronic, Medtrum Technologies, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker’s Bureau; Self; BD, Medtronic, Sanofi. K. N. Castorino: Consultant; Self; Dexcom, Inc., Research Support; Self; Abbott Diabetes, Abbott Laboratories, Dexcom, Inc., Drawbridge Health, Inc., Lilly Diabetes, Medtronic, Novo Nordisk Inc. D. S. Denham: None. E. Kerwin: Consultant; Self; Amphastar, AstraZeneca, Connect Biopharma, GlaxoSmithKline plc., Mylan N. V., Novartis Pharmaceuticals Corporation, Sunovion Pharmaceuticals Inc., Theravance Biopharma, Speaker’s Bureau; Self; Chiesi USA, Inc. M. Mickiewicz: None.

37-LB: Very-Low-Dose Premeal Whey Protein Microgels Reduce Postprandial (PP) Glucose in Type 2 Diabetes: A Randomized, Placebo-Controlled Crossover Study

Whey protein (WP), found in dairy products, is rich in branched chain amino acids and bioactive peptides that stimulate the secretion of incretin hormones and insulin, but has typically required relatively high caloric doses. Technologies enhancing absorption could enable use of a lower WP-dose. This single-intervention study in type 2 diabetes (drug-naïve or on metformin), evaluated the effects of 10g WP (40 Cal) prepared with novel micelle-technology [WPM], or placebo (PBO, 0 Cal), taken as a 125 mL shot 15 min ahead of a pizza meal (622 Cal). PP glucose (0-4h) and intact GLP-1 (0-2h) responses were assessed in blood. Twenty-six individuals (mean age 62 years, baseline HbA1c 7,5%, BMI 29.1 kg/m2) completed both sequences. Compared to PBO, pre-meal WPM significantly altered the early PP glucose trajectory (Fig), reducing the 2h incremental area under the curve (iAUC) by 22% (mean [95% CI] difference iAUC-30-120min -29.43 [-55.45, -3.40] mg/dLxh, p=0.0283). The iAUC-30-180min was similar (-31.58 [-68.43, 5.26], p=0.0896). A 66.1% increase in GLP-1 iAUC-30-120min was observed (4.80 [2.19, 7.40], p=0.0009). Compared to PBO, 10g WPM taken 15 min before a pizza meal, significantly reduced the early glycemic burden and significantly augmented the GLP-1 response, suggesting its use as a convenient pre-meal shot to improve PP metabolic profile in type 2 diabetes.View largeDownload slideView largeDownload slide DisclosureL. H. De gregorio: Research Support; Self; Nestlé, Novartis Pharmaceuticals Corporation. O. E. Johansen: Employee; Self; Boehringer Ingelheim International GmbH, Nestlé. I. Neeland: Consultant; Self; Merck & Co., Inc. R. Zagury: Board Member; Self; Abbott, Consultant; Self; Nestlé, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Danone Nutricia, Novo Nordisk Pharma Ltd., Sanofi, Servier Laboratories. B. Ahrén: Stock/Shareholder; Self; AstraZeneca, Novo Nordisk Inc. J. M. Neutel: None. K. Reyes: Employee; Self; Nestlé. E. Perrin: Other Relationship; Self; Nestlé. E. Berk: Employee; Self; Nestle Health Science. M. Von eynatten: Employee; Self; Nestlé.FundingNestlé Health Science

197-OR: ADO09, a Coformulation of Insulin A21G and Pramlintide (Pram), Improves Blood Glucose Control and Reduces Body Weight in Subjects with T1D

ADO09 is a co-formulation of Pram and insulin A21G developed to deliver the positive effects of Pram without additional injections. This double-blind randomized cross-over trial investigated the effects of pre-meal ADO09 vs. insulin aspart (ASP) on mixed meal tolerance tests (MMTT) and CGM over 24 days in 16 T1D subjects (BMI 30.5 ± 3.1 kg/m²) using daily prandial insulin doses of 45-75 U. ADO09 reduced incremental AUC glucose 0-4h during MMTT by 69% (p=0.006) and deltaPG 1h by 82 mg/dL (p<0.001) vs. ASP (figure). Post-meal glucagon levels were lowered by up to 85% and speed of gastric emptying (acetaminophen absorption) reduced by >50% with ADO09. CGM over the final 3 weeks showed higher time in range (+58 min), lower time >180 mg/dL (-71 min) and slightly higher time <70 mg/dL (+13mins) with ADO09. Body weight decreased by 1.6 kg with ADO09 (p=0.007) as did daily prandial insulin doses (-12 U vs. ASP, median 35.0 U vs. 47.3; p=0.0004). Slightly more hypoglycemic episodes were noted with ADO09 (n=96 vs. 79) with no difference in nocturnal hypoglycemia. While more adverse events (AEs) occurred with ADO09 (22 vs. 10), most AEs were mild and of gastro-intestinal nature (nausea, decreased appetite).In conclusion, ADO09 improved blood glucose control and reduced both body weight and prandial insulin doses vs. insulin aspart in T1D subjects with high prandial insulin needs.View largeDownload slideView largeDownload slide DisclosureG. Meiffren: Employee; Self; ADOCIA, Stock/Shareholder; Self; ADOCIA. J. Devries: Advisory Panel; Self; ADOCIA, Novo Nordisk Inc., Zealand Pharma A/S, Speaker’s Bureau; Self; Novo Nordisk Inc. T. Heise: Advisory Panel; Self; Novo Nordisk A/S, Valbiotis, Research Support; Self; ADOCIA, Afon Technology Ltd., AstraZeneca, Biocon, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Gan & Lee Pharmaceuticals, Johnson & Johnson, Julphar, Mylan N. V., Nestlé, Neuraly, Nordic Bioscience, Novo Nordisk, Sanofi, Zealand Pharma A/S, Speaker’s Bureau; Self; Novo Nordisk A/S. G. Andersen: None. R. Eloy: Employee; Self; ADOCIA, Stock/Shareholder; Self; ADOCIA. C. Mégret: Employee; Self; ADOCIA, Stock/Shareholder; Self; ADOCIA. S. Famulla: None. C. Seroussi: Employee; Self; ADOCIA, Stock/Shareholder; Self; ADOCIA. Y. Chan: Employee; Self; ADOCIA. M. Gaudier: Employee; Self; ADOCIA, Stock/Shareholder; Self; ADOCIA. O. Soula: Employee; Self; ADOCIA, Employee; Spouse/Partner; ADOCIA, Stock/Shareholder; Self; ADOCIA, Stock/Shareholder; Spouse/Partner; ADOCIA.

100-LB: Infusion Set Survival and Performance during the Medtronic Extended-Wear Infusion Set (EWIS) Pivotal Trial

Objective: Most insulin infusion sets (ISs) are labeled for 2- or 3-days use. The Medtronic EWIS is designed to increase wear time up to 7 days. This study reports on EWIS survival and performance during the pivotal trial (ClinicalTrials.gov: NCT04113694).Method: This multi-center (15), single-arm, non-randomized, non-inferiority trial in 259 participants (18-80yrs) with T1D using the MiniMed™ 670G system (with Humalog™ or Novolog™ insulin) involved wearing a 2- or 3-day IS for 2 weeks (run-in) followed by 12 consecutive EWIS wears (study phase). The latter was worn for ≥174 hours or until set failure. Safety and performance (i.e., a priori target of <16% failure rate due to unexplained hyperglycemia) were evaluated. Exploratory analysis of glycemic control (e.g., A1C, sensor glucose and time spent at glucose ranges) and insulin use during 3-day IS and EWIS wear were also evaluated.Result: The EWIS survival rate was 74.8% versus the 67.7% rate of 2- or 3-day ISs (p<0.05). The EWIS rate was 77.8% when excluding inadvertent early removals. Glycemic control outcomes were improved during EWIS use (Table) and there were no episodes of EWIS-related severe hypoglycemia or DKA.Conclusion: The 7-day EWIS was safe and its performance was superior at ≥174 hours compared to the performance observed for 2- or 3-day infusion sets.View largeDownload slideView largeDownload slide DisclosureB. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. B. Horowitz: Research Support; Self; Abbott Laboratories, BD, Celgene, Crinetics Pharmaceuticals, Gan & Lee Pharmaceuticals, Medtronic, Speaker’s Bureau; Self; AstraZeneca, Lilly Diabetes, Merck & Co., Inc., Novo Nordisk Inc. K. B. Kaiserman: Advisory Panel; Self; Medtronic, Consultant; Self; Medtronic, Employee; Self; MannKind Corporation, Research Support; Self; Medtronic, Speaker’s Bureau; Self; Medtronic, Stock/Shareholder; Self; MannKind Corporation. S. Huang: None. V. Chen: Employee; Self; Medtronic. G. Zhang: Employee; Self; Medtronic. S. Chattaraj: Employee; Self; Medtronic. J. Shin: Employee; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic. R. L. Brazg: Research Support; Self; Abbott Diabetes, Ascensia Diabetes Care, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Pfizer Inc., Roche Diagnostic USA, Senseonics. T. S. Bailey: Consultant; Self; Abbott Diabetes, LifeScan, Novo Nordisk, Sanofi, Research Support; Self; Abbott, Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Livongo, Medtronic, Medtrum Technologies, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker’s Bureau; Self; BD, Medtronic, Sanofi. Y. C. Kudva: Research Support; Self; Dexcom, Inc. S. K. Garg: Advisory Panel; Self; Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. G. Grunberger: Research Support; Self; Medtronic, Speaker’s Bureau; Self; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk. J. Thrasher: Advisory Panel; Self; Medtronic, Board Member; Self; Medtronic, Consultant; Self; Medtronic, Research Support; Self; Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Mylan N. V., Novo Nordisk, Sanofi, Speaker’s Bureau; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Medtronic, Sanofi. A. Cavale: Research Support; Self; Eli Lilly and Company, Medtronic. A. Bhargava: Research Support; Self; Abbott, AbbVie Inc., Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Boston Therapeutics, Inc., Covance Inc., Dexcom, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Insulet Corporation, Janssen Research & Development, LLC, Kowa Pharmaceuticals America, Inc., Madrigal Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Mylan N. V., Novo Nordisk, Poxel SA, Quintiles, Sanofi, Senseonics, Tolerion, Inc., Viking Therapeutics.