Individualized HbA1c Targets Research Articles

Retrospective Study of IDegLira, a New Fixed-Ratio Combination, in Japanese Patients With Type 2 Diabetes Mellitus: Analysis of Background Factors Affecting Effectiveness After 6 Months of Treatment.

The aim of the study was to provide real-world data on the effectiveness and safety of a new fixed-ratio combination, insulin degludec/liraglutide (IDegLira) injection in Japanese patients with type 2 diabetes mellitus (T2DM). The primary endpoint was the change in glycated hemoglobin (HbA1c) level 6 months after the introduction of IDegLira. We also examined the rate of achievement of target HbA1c 7% and the individualized HbA1c targets set for each patient. Baseline characteristics associated with the change in HbA1c were also assessed. Seventy-five patients with T2DM were included in the analysis. After the initiation of IDegLira, HbA1c decreased significantly from baseline with a change of -1.81% (baseline 9.61% and at 6 months 7.80%; P < 0.001). At baseline, the achievement rate of 7% HbA1c was 2.67% (n = 2), which increased to 36.0% (n = 27) after 6 months of IDegLira introduction (P < 0.05). The attainment rate of individualized HbA1c targets, which were set considering each patient's characteristics, improved from 2.67% (n = 2) to 49.3% (n = 37) (P < 0.001). Regardless of sex, body mass index, estimated glomerular filtration rate, duration of diabetes, or history of glucagon-like peptide-1 receptor agonist use, IDegLira significantly reduced HbA1c, but a higher C-peptide index was associated with a greater reduction in HbA1c. In this study, initiation of IDegLira in a real-world clinical setting was beneficial in lowering HbA1c in Japanese T2DM patients with inadequate glycemic control with existing therapy.

1056-P: Impact of Individualized HbA1c Target Setting on Diabetes-Distress, Self-Efficacy, Well-Being, and HbA1c

American Diabetes Association guidelines emphasize the importance of individualized HbA1c target setting in glycemic management, but little is known of the impact of target-setting on patient well-being. We randomized 50 adults (type 1 or 2) to receive HbA1c targets 5 mmol/mol (0.5%) above or below current value and evaluated impact on health-related quality of life: EQ-5D-5L, EQ-VAS, diabetes distress: Problem Areas in Diabetes, PAID, self-efficacy: Diabetes Empowerment Scale Long Form, DES-LF, well-being: Wellbeing Questionnaire-12, W-BQ12 and HbA1c (%) at baseline and 3 months; with thematic analysis of semi-structured interviews in a subset of 14 people. Tabulated results for 33 completers: We hypothesized that individualized target-setting, especially stretch targets, might worsen diabetes distress and compromise wellbeing. Multiple validated questionnaires and thematic analysis of semi-structured interviews showed no evidence of any significant deterioration. Indeed, the process of explicit individualized target setting was associated with improvements in all wellbeing measures except EQ-5D-5L and there were significant improvements in diabetes distress and psychosocial efficacy in the relaxed target group. Our data suggest that the process of setting explicit individualized HbA1c targets is a positive one, regardless of whether the target is ‘relaxed’ or ‘stretch’. Disclosure S.J.Westall: None. S.Watmough: None. R.Narayanan: None. G.Irving: Research Support; Graphnet, Takeda Pharmaceutical Co., Ltd. N.J.Furlong: None. G.A.Lewis: None. K.J.Hardy: Other Relationship; Sanofi, Speaker's Bureau; Napp Pharmaceuticals Limited.

Gaps Remain for Achieving HbA1c Targets for People with Type 1 or Type 2 Diabetes Using Insulin: Results from NHANES 2009-2020.

Glycated hemoglobin A1c (HbA1c) is an important measure to assess glycemic control and predict diabetes complications. However, there is limited information on trends in HbA1c among people with diabetes (PwDs) who use insulin. The aim of this study was to describe trends in HbA1c among PwDs who use insulin by diabetes type and insulin regimen. A retrospective analysis was conducted using data from the National Health and Nutrition Examination Survey (NHANES, 2009-2020). PwDs were classified into three cohorts: type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus using mealtime insulin (T2DM-MTI), and type 2 diabetes mellitus (T2DM) using basal-only insulin (T2DM basal-only). Trends in HbA1c over time were assessed using regression analysis after adjusting for age, gender, and race/ethnicity. Mean HbA1c values aggregated over 2009-2020 were 8.0% (T1DM), 8.6% (T2DM-MTI), and 8.6% (T2DM basal-only). The American Diabetes Association-recommended target of HbA1c of < 7% was achieved by 25.2% of people in the T1DM and T2DM-MTI groups each and by 12.3% of people in the T2DM basal-only group. Over time, an upward trend was observed in the percentage of people achieving HbA1c < 7% in the T2DM basal-only group. The percentage of PwDs achieving individualized HbA1c targets was 27.0%, 12.4%, and 16.1% for the T1DM, T2DM-MTI, and T2DM basal-only groups, respectively. Our study using NHANES data suggests that approximately 25% of PwDs achieve glycemic targets. This study highlights the need for improved therapies to better manage glycemic targets in PwDs.

Short-term effectiveness of dapagliflozin versus DPP-4 inhibitors in elderly patients with type 2 diabetes: a multicentre retrospective study

AimTo compare effectiveness of dapagliflozin versus DPP-4 inhibitors on individualized HbA1c targets and extra-glycaemic endpoints among elderly patients with type 2 diabetes (T2D).MethodsThis was a multicentre retrospective study on patients aged 70–80 years with HbA1c above individualized target and starting dapagliflozin or DPP-4 inhibitors in 2015–2017. The primary outcome was the proportion reaching individualized HbA1c targets. Confounding by indication was addressed by inverse probability of treatment weighting (IPTW), multivariable adjustment (MVA), or propensity score matching (PSM).ResultsPatients initiating dapagliflozin (n = 445) differed from those initiating DPP-4i (n = 977) and balance between groups was achieved with IPTW or PSM. The median follow-up was 7.5 months and baseline HbA1c was 8.3%. A smaller proportion of patients initiating dapagliflozin attained individualized HbA1c target as compared to those initiating DPP-4 inhibitors (RR 0.73, p < 0.0001). IPTW, MVA, and PSM yielded similar results. Between-group difference in the primary outcome was observed among patients with lower eGFR or longer disease duration. Dapagliflozin allowed greater reductions in body weight and blood pressure than DPP-4 inhibitors.ConclusionsElderly patients with T2D initiating dapagliflozin had a lower probability of achieving individualized HbA1c targets than those initiating DPP-4 inhibitors but displayed better improvements in extra-glycaemic endpoints.

A sub-analysis of the SAGE study in Italy indicates good glycemic control in type 1 diabetes

Background and aimsIntensive glycemic control minimizes the risk of micro- and macrovascular complications in patients with type 1 diabetes (T1D). We report glycemic control in Italian participants (age groups: 26–44, 45–64, and ≥65 years) of the global SAGE study. Methods and resultsThe primary endpoint was proportion of participants who achieved an HbA1c <7% in predefined age groups. In the 523 patients with T1D, mean age was 44.6 years and mean body mass index (BMI) was 25 kg/m2. Mean HbA1c was 7.5% and 29.4% had HbA1c <7.0%, with the highest percentage in those 26–45 years (31.7%) and the lowest in those ≥65 years (20%). Altogether, 22.9% of patients achieved their physician-established individualized HbA1c target. Most patients had ≥1 symptomatic hypoglycemic episode in the previous 3 months (≤70 mg/dL 82.5%; ≤54 mg/dL 61%). Severe hypo- and hyperglycemia were experienced by 16.3% and 12% of patients, of which 7.1 and 9.5%, respectively, required hospitalization/emergency visits. More patients achieved HbA1c <7% with CSII (30%) than with multiple daily insulin injections (27.9%). In multivariate analysis, BMI (OR 0.94, 95% CI 0.89–0.99, p = 0.032) and adherence to diet (OR 0.36, 95% CI 0.18–0.70, p = 0.0028) were significantly associated with HbA1c <7.0%. ConclusionsGlycemic control can be considered good in the Italian SAGE cohort, especially in younger patients, who more frequently use pumps/continuous glucose monitoring. Greater patient education and use of technology may further support this achievement. Patients should be encouraged to maintain a low BMI and adhere to their diet.

ATOS study: effectiveness and safety of insulin glargine 300 U/mL in the real world clinical practice in insulin-naïve type 2 diabetic patients in the Russian Federation

Rationale: Basal insulin glargine 300 U/mL (Gla-300) is a second-generation basal insulin analogue that has comparable efficacy and lower variability compared to the first generation long-acting insulin analogue glargine 100 U/mL.&#x0D; Aim: To assess the effectiveness and safety of Gla-300 in insulin-nave type 2 diabetic patients in the real world practice in Russia.&#x0D; Materials and methods: ATOS (NCT03703869) was a 12-month, prospective observational international multicenter study. The study included 4422 adults ( 18 years) with uncontrolled type 2 diabetes (HbA1c 7 and 11%) with 1 oral anti-hyperglycemic drug and for whom the treating physician had decided to add Gla-300. We performed a post-hoc sub-analysis of the study participants recruited in Russia.&#x0D; Results: The Russian study group included 1493 patients receiving Gla-300. At 6 months, 25.9% of the patients achieved their predefined individualized HbA1c target and 53.3% achieved their HbA1c target at month 12. Their mean ( SD) HbA1c level decreased from 9.3 0.9% at baseline to 7.6 0.7% and 7.2 0.7 at months 6 and 12. The incidence of hypoglycemia was generally low; overall, severe hypoglycemia was reported only in 0.07% and 0.13% of the patients at 6 and 12 months. The baseline average daily dose of Gla-300 was 13.2 4.9 Units; it to 23.6 9.1 and 26.0 9.8 Units at months 6 and 12.&#x0D; Conclusion: In the real world setting, initiation of insulin Gla-300 in type 2 diabetic patients who had been out of their target glucose range with oral hypoglycemic agents is associated with improved glycemic control and low risk of hypoglycemia.

Role of therapeutic inertia in glycemic control according to individualized objectives in a cohort of patients with type 2 diabetes. Results from CONCARDIA2

Background and objectiveTherapeutic inertia (TI) is the lack of initiation or intensification of treatment when indicated. It contributes to the fact that more than a third of people with type 2 diabetes mellitus (T2D) do not have adequate metabolic control. We set out to analyze the impact of TI during 4 years of follow-up in a cohort of T2D and its possible variables. Materials and methodsProspective cohort study of a cohort of 297 TD2 patients. We considered TI when treatment was not modified during the 4 years, despite poor control. We contemplate uncontrolled those that did not meet their individualized HbA1c target. ResultsUncontrolled patients: 87; age: 62.2 ± 9.2; 58.7% men. We consider TI in 41.6% of the patients. Average HbA1c 8.22% in patients with treatment intensification of which 43.1% achieved their HbA1c goal, 29.8% were on monotherapy at the beginning, 29.8% double, 36.2% triple and 2,1% in quadruple therapy. There was more change in treatment in people with obesity (67.6 vs. 34.6%; P < 0.01) and the 6 of the study patients with cardiovascular events (P < 0.05). Metformin was part of the treatment in 97.1% of IT cases (vs. 76.6%; P < 0.01). Achievement of the HbA1c target was higher in patients receiving iSGLT2 (0 vs. 68.4%; P < 0.001). ConclusionsIn 2 out of 5 uncontrolled T2D patients, the treatment was not changed; this was more evident in those patients treated with metformin. Patients with obesity and presence of cardiovascular events seem to protect against IT. Those who were on iSGLT2 have an advantage in meeting their HbA1c target.

Effectiveness of a Diabetes-Focused Electronic Discharge Order Set and Postdischarge Nursing Support Among Poorly Controlled Hospitalized Patients: Randomized Controlled Trial.

BackgroundAlthough the use of electronic order sets has become standard practice for inpatient diabetes management, there is limited decision support at discharge.ObjectiveIn this study, we assessed whether an electronic discharge order set (DOS) plus nurse follow-up calls improve discharge orders and postdischarge outcomes among hospitalized patients with type 2 diabetes mellitus.MethodsThis was a randomized, open-label, single center study that compared an electronic DOS and nurse phone calls to enhanced standard care (ESC) in hospitalized insulin-requiring patients with type 2 diabetes mellitus. The primary outcome was change in glycated hemoglobin (HbA1c) level at 24 weeks after discharge. The secondary outcomes included the completeness and accuracy of discharge prescriptions related to diabetes.ResultsThis study was stopped early because of feasibility concerns related to the long-term follow-up. However, 158 participants were enrolled (DOS: n=82; ESC: n=76), of whom 155 had discharge data. The DOS group had a greater frequency of prescriptions for bolus insulin (78% vs 44%; P=.01), needles or syringes (95% vs 63%; P=.03), and glucometers (86% vs 36%; P<.001). The clarity of the orders was similar. HbA1c data were available for 54 participants in each arm at 12 weeks and for 44 and 45 participants in the DOS and ESC arms, respectively, at 24 weeks. The unadjusted difference in change in HbA1c level (DOS – ESC) was −0.6% (SD 0.4%; P=.18) at 12 weeks and −1.1% (SD 0.4%; P=.01) at 24 weeks. The adjusted difference in change in HbA1c level was −0.5% (SD 0.4%; P=.20) at 12 weeks and −0.7% (SD 0.4%; P=.09) at 24 weeks. The achievement of the individualized HbA1c target was greater in the DOS group at 12 weeks but not at 24 weeks.ConclusionsAn intervention that included a DOS plus a postdischarge nurse phone call resulted in more complete discharge prescriptions. The assessment of postdischarge outcomes was limited, owing to the loss of the long-term follow-up, but it suggested a possible benefit in glucose control.Trial RegistrationClinicalTrials.gov NCT03455985; https://clinicaltrials.gov/ct2/show/NCT03455985

658-P: Gaps Remain for Achieving Guideline-Recommended and Individualized HbA1c Targets for People with Type 1 and Type 2 Diabetes Using Mealtime Insulin or Basal-Only Insulin

Background: HbA1c is a primary measure of glycemic control and managing HbA1c may help reduce the risk of complications. This study aimed to describe trends in HbA1c by insulin regimen. Methods: This was a retrospective analysis of cross-sectional surveys collected from the National Health and Nutrition Examination Survey between 2009-2018. Mean HbA1c and proportion achieving guideline- and HCP-recommended (i.e. personalized) HbA1c targets were evaluated in aggregate and over time in adults (18-64 years) with type 1 (T1DM) or type 2 (T2DM) diabetes using mealtime insulin (MTI) or basal insulin only. Trends over time between 2009-2018 were evaluated after adjusting for age, gender, race/ethnicity. The analysis included the strata, clusters, and weighting of the complex survey design. Results: From 2009-2018, 26.1% of people with T1DM (weighted n=891,194; mean HbA1c [SE] 7.9% [0.2]) , 24.8% with T2DM MTI (weighted n=1,591,183; mean HbA1c [SE] 8.6% [0.2]) , and 11.2% with T2DM basal only (weighted n=1,087,895; mean HbA1c [SE] 8.6% [0.2]) achieved the ADA recommended HbA1c goal of &amp;lt;7%. Among those who reported personalized HbA1c goals, 28.7% (T1DM) , 9.5% (T2DM MTI) , and 17.1% (T2DM basal only) achieved their goals. After adjustment, the proportion of people achieving HbA1c &amp;lt;7% in the basal only group increased significantly over time (2009-2018; p=0.04) , driven by an increase in 2017-2018. Adjusted mean HbA1c for T2DM MTI significantly decreased during the 2009-2018 timeframe (p=0.003) , whereas no significant differences were seen in the other subgroups. Conclusions: Across all insulin regimens based off the most recent NHANES data, ∼75-90% of individuals are not achieving ADA-recommended or personalized HbA1c goals. Emerging treatment tools (e.g. new technologies, advanced insulins, and time in range metrics) may facilitate improved diabetes outcomes. Disclosure E.R.Hankosky: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. D.Schapiro: Employee; Eli Lilly and Company. K.B.Gunn: Employee; Eli Lilly and Company. E.Lubelczyk: Employee; Eli Lilly and Company. J.Mitroi: None. D.R.Nelson: Employee; Eli Lilly and Company. Funding Eli Lilly and Company

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 &amp;lt;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 &amp;gt;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

POS-312 HbA1C AND OUTCOMES IN PATIENTS WITH CKD STAGE 3b AND 4

Currently, there is limited data available to guide glycemic control in patients with CKD stages 3B and 4 as patients with advanced chronic kidney disease (CKD) are mostly excluded from clinical trials. The KDIGO CKD guidelines in 2012 recommend a target HbA1c of about 7.0% to prevent or delay progression of the microvascular complications of diabetes including diabetic kidney disease (DKD). The latest KDIGO 2020 Guidelines recommend an individualized HbA1c target ranging from <6.5% to <8.0% in patients with DM and CKD not on dialysis.

Three-Year Glycaemic Control and Management in Patients with Type2 Diabetes Initiating Second-Line Treatment in Japan: A Prospective Observational Study, J-DISCOVER.

IntroductionJ-DISCOVER is a prospective, observational cohort study that aimed to understand characteristics, glycaemic control, comorbidities and real-world management of patients with early-stage type 2 diabetes mellitus (T2DM) in Japan, by enrolling patients initiating second-line treatment from both diabetes specialist and non-specialist care settings.MethodsAs part of the global DISCOVER programme, J-DISCOVER enrolled 1798 patients with T2DM aged at least 20 years old from 142 sites across Japan, from September 2014 to December 2015, and followed these patients for 3 years. Glycaemic control, body mass index (BMI), blood pressure, lipid profiles, treatment patterns, and prevalence of CKD and retinopathy were examined from baseline to 6, 12, 24 and 36 months, stratified by class of second-line treatment.ResultsAt baseline, the median time after T2DM diagnosis was 3.1 years and mean glycated haemoglobin (HbA1c) was 7.7%. The mean individualized HbA1c target was 6.7 ± 0.5%, and 55.3% of patients were set the target of < 7.0%. HbA1c reductions were noted from 6 months and mean HbA1c was 7.1% at 36 months. The proportion of patients with HbA1c < 7.0% increased from 28.8% at baseline to 53.3% at 36 months, and the achievement rate of individualized HbA1c targets increased from 6.1% to 30.3%. Only two cases of severe hypoglycaemia occurred during the study. No major changes in BMI, blood pressure, lipid profile or prescription of antihypertensive or dyslipidaemia medications were observed. The frequencies of screening to detect retinopathy and chronic kidney disease (CKD) were 17.0–21.0% and 14.5–16.0%, respectively, during the follow-up period. The prevalence of CKD, but not retinopathy, increased over the follow-up period.ConclusionsThis study provided an overview of the 3-year management of early-stage T2DM in patients initiating second-line treatment. Contemporary management improved glycaemic control with an acceptable risk–benefit balance, although hurdles remain to sufficient implementation of guideline-recommended treatments in current clinical practice.Trial RegistrationClinicalTrials.gov identifier, NCT02226822.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01192-x.

Inercia terapéutica en el control glucémico según objetivos individualizados en una cohorte de pacientes con diabetes tipo 2: resultados del estudio CONCARDIA2

Background and objectiveTherapeutic inertia (TI) is the lack of initiation or intensification of treatment when indicated. It contributes to the fact that more than a third of people with type 2 diabetes mellitus (T2D) do not have adequate metabolic control. We set out to analyze the impact of TI during 4 years of follow-up in a cohort of T2D and its possible variables. Materials and methodsProspective cohort study of a cohort of 297 TD2 patients. We considered TI when treatment was not modified during the 4 years, despite poor control. We contemplate uncontrolled those that did not meet their individualized HbA1c target. ResultsUncontrolled patients: 87; age: 62.2±9.2; 58.7% men. We consider TI in 41.6% of the patients. Average HbA1c 8.22% in patients with treatment intensification of which 43.1% achieved their HbA1c goal, 29.8% were on monotherapy at the beginning, 29.8% double, 36.2% triple and 2,1% in quadruple therapy. There was more change in treatment in people with obesity (67.6 vs. 34.6%; P<0.01) and the 6 of the study patients with cardiovascular events (P<0.05). Metformin was part of the treatment in 97.1% of IT cases (vs. 76.6%; P<0.01). Achievement of the HbA1c target was higher in patients receiving iSGLT2 (0 vs. 68.4%; P<0.001). ConclusionsIn 2out of 5uncontrolled T2D patients, the treatment was not changed; this was more evident in those patients treated with metformin. Patients with obesity and presence of cardiovascular events seem to protect against IT. Those who were on iSGLT2 have an advantage in meeting their HbA1c target.

Individualized HbA1c target selection and achievement in the Multinational Observational Study Assessing Insulin Use (MOSA1c) type 2 diabetes study.

To identify which individual-, physician-, and the healthcare system-related factors can predict individualized hemoglobin A1c (HbA1c) targets and the likelihood of reaching those targets after initial insulin therapy over a two-year follow-up period. Real-world data, including baseline characteristics of people with type 2 diabetes mellitus (T2DM), psychosocial data, and diabetes medication use, collected from the Multinational Observational Study Assessing Insulin Use (MOSA1c) study in 18 countries were analyzed. Overall, 225 of 1194 people with T2DM (18.8%) who received initial insulin therapy for ≥3months reached HbA1c targets at two-year follow-up; most were likely to be White (64.9%) and perceptions of their relationship with physicians were less positive than those who did not reach HbA1c targets. Higher baseline HbA1c (>8%) was the strongest predictor of being assigned an HbA1c target >7% (odds ratio [OR] 6.06, 95% confidence interval [CI] 3.97, 9.26). A smaller difference between baseline and target HbA1c levels was the strongest predictor of reaching an HbA1c target at two-year follow-up (large vs small difference, OR 0.28, 95% CI 0.17, 0.47). Several factors were significantly associated with establishing individualized HbA1c targets and reaching these targets. A small proportion of people with T2DM on insulin therapy reached their HbA1c target. Personalized management of glycemic targets necessitates the adoption of multi-factorial strategies, as several factors could influence an individual's glycemic outcome. CLINICALTRIALS. NCT01400971.

Switching the basal insulin to insulin glargine 300 U/ml in people with type 2 diabetes under basal insulin supported oral therapy: Observational trial on effectiveness and safety.

This study evaluated the effectiveness and safety of switching the basal insulin (BI) in a BI-supported oral therapy (BOT) to insulin glargine 300 U/ml (Gla-300) in adults with inadequately controlled type 2 diabetes (T2D). This was a non-interventional, multicentre, prospective 12-month study, conducted in Germany, Austria and Switzerland. The study documented people with T2D with glycated haemoglobin (HbA1c) between 7.5% and 10.0%, currently treated by a non-Gla-300 BOT regimen, after the physician had decided to switch the BI to Gla-300. Primary endpoint was the proportion of patients achieving the fasting plasma glucose (FPG; ≤110 mg/dl) target. In total, 1194 participants comprised the full analysis set, of which 793 completed documentation of 12 months Gla-300 treatment (FAS-M12). The main previous BI was insulin glargine 100 U/ml (Gla-100; 47.2%). Twelve months after switching to Gla-300, 27.0% of FAS-M12 participants achieved the FPG target and 44.8% their individualized HbA1c target. The greatest FPG target achievements were seen in previous Gla-100 (29.3%), and greatest HbA1c target achievements in previous insulin detemir users (57.7%). The mean FPG decreased by -36.3 ± 51.2mg/dl to 135.5 ± 36.9mg/dl and mean HbA1c by -0.79 ± 1.01% to 7.45 ± 0.94%. Symptomatic and nocturnal hypoglycaemia incidence significantly decreased over 12 months of Gla-300 treatment. Body weight remained unchanged. Switching the BI to Gla-300 in a BOT regimen improved metabolic control and treatment satisfaction in a substantial proportion of patients with T2D and inadequate target achievement within 12 months in clinical practice with a decreased risk of symptomatic and nocturnal hypoglycaemia and without weight gain.

Trends in Prevalence of Diabetes and Control of Risk Factors in Diabetes Among US Adults, 1999-2018

Understanding population-wide trends in prevalence and control of diabetes is critical to planning public health approaches for prevention and management of the disease. To determine trends in prevalence of diabetes and control of risk factors in diabetes among US adults between 1999-2000 and 2017-2018. Ten cycles of cross-sectional National Health and Nutrition Examination Survey (NHANES) data between 1999-2000 and 2017-2018 were included. The study samples were weighted to be representative of the noninstitutionalized civilian resident US population. Adults aged 18 years or older were included, except pregnant women. Survey cycle. Diabetes was defined by self-report of diabetes diagnosis, fasting plasma glucose level of 126 mg/dL or more, or hemoglobin A1c (HbA1c) level of 6.5% or more. Three risk factor control goals were individualized HbA1c targets, blood pressure less than 130/80 mm Hg, and low-density lipoprotein cholesterol level less than 100 mg/dL. Prevalence of diabetes and proportion of adults with diagnosed diabetes who achieved risk factor control goals, overall and by sociodemographic variables, were estimated. Among the 28 143 participants included (weighted mean age, 48.2 years; 49.3% men), the estimated age-standardized prevalence of diabetes increased significantly from 9.8% (95% CI, 8.6%-11.1%) in 1999-2000 to 14.3% (95% CI, 12.9%-15.8%) in 2017-2018 (P for trend < .001). From 1999-2002 to 2015-2018, the estimated age-standardized proportion of adults with diagnosed diabetes who achieved blood pressure less than 130/80 mm Hg (P for trend = .007) and low-density lipoprotein cholesterol level less than 100 mg/dL (P for trend < .001) increased significantly, but not individualized HbA1c targets (P for trend = .51). In 2015-2018, 66.8% (95% CI, 63.2%-70.4%), 48.2% (95% CI, 44.6%-51.8%), and 59.7% (95% CI, 54.2%-65.2%) of adults with diagnosed diabetes achieved individualized HbA1c targets, blood pressure less than 130/80 mm Hg, and low-density lipoprotein cholesterol level less than 100 mg/dL, respectively. Only 21.2% of these adults (95% CI, 15.5%-26.8%) achieved all 3. During the entire study period, these 3 goals were significantly less likely to be achieved among young adults aged 18 to 44 years (vs older adults ≥65 years: estimated proportion, 7.4% vs 21.7%; adjusted odds ratio, 0.32 [95% CI, 0.16-0.63]), non-Hispanic Black adults (vs non-Hispanic White adults: estimated age-standardized proportion, 12.5% vs 20.6%; adjusted odds ratio, 0.60 [95% CI, 0.40-0.90]), and Mexican American adults (vs non-Hispanic White adults: estimated age-standardized proportion, 10.9% vs 20.6%; adjusted odds ratio, 0.48 [95% CI, 0.31-0.77]). Based on NHANES data from US adults, the estimated prevalence of diabetes increased significantly between 1999-2000 and 2017-2018. Only an estimated 21% of adults with diagnosed diabetes achieved all 3 risk factor control goals in 2015-2018.

672-P: The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES): Twelve-Month Data Analysis

TROPHIES is a 24-month, prospective, non-comparative, observational study in adult patients with T2D initiating their first injectable glucose-lowering treatment with once-weekly dulaglutide (DU) or once-daily liraglutide (LIRA) in France, Germany, and Italy. Patient disposition, clinical characteristics, and GLP-1 RA persistence at 12-months are described for 1112 DU and 1039 LIRA patients eligible for analysis. The 12-month mean HbA1c (SD) change from baseline was -1.2 (1.4)% (baseline, 8.2 (1.2)%) in the DU cohort and -1.2 (1.5)% (baseline, 8.3 (1.3)%) in the LIRA cohort. At 12-months, 35% DU and 29% LIRA patients reached their individualized HbA1c target set by the physician at baseline. The mean weight change for DU and LIRA from baseline to 12-months was -3.3 (5.5) kg and -3.4 (6.1) kg, respectively. Probability (95%CI) of GLP-1 RA persistence was high in both DU and LIRA cohorts at 12-months: DU, 0.88 (0.86-0.90); LIRA 0.82 (0.79-0.84); (Figure).In summary, these data show similar HbA1c and weight reductions for DU and LIRA at 12-months with good persistence, consistent with known clinical trial results.View largeDownload slideView largeDownload slide DisclosureB. Guerci: Advisory Panel; Self; Abbott, Novartis Pharmaceuticals Corporation, Board Member; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk, Sanofi, Consultant; Self; AstraZeneca, Intercept Pharmaceuticals, Inc. M. O. Orsini federici: Employee; Self; Eli Lilly and Company. F. Giorgino: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk, Roche Diabetes Care, Sanofi, Research Support; Self; Lilly Diabetes, Roche Diabetes Care. L. Garcia: Employee; Self; Eli Lilly and Company. K. Boye: Employee; Self; Eli Lilly and Company, Employee; Spouse/Partner; Eli Lilly and Company. K. Norrbacka: Employee; Self; Oy Eli Lilly Finland Ab, Stock/Shareholder; Self; Eli Lilly and Company. H. Sapin: Employee; Self; Eli Lilly and Company. E. Heitmann: Employee; Self; Lilly Diabetes. J. Lebrec: Consultant; Self; Eli Lilly and Company. A. Dib: Advisory Panel; Spouse/Partner; Boehringer Ingelheim Pharmaceuticals, Inc., Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company.

Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL in Patients with T2D Uncontrolled on NPH or Premixed Insulins as Part of Routine Clinical Practice in Bulgaria: ToUPGRADE Study

IntroductionThe aim of this study is to demonstrate the real-life effectiveness and safety of insulin glargine 300 U/mL (Gla-300) in patients with type 2 diabetes (T2D) previously uncontrolled on NPH ± prandial insulin or premixed insulins in routine clinical practice in Bulgaria.MethodsThis was a 24-week prospective, observational study performed in 40 inpatient and outpatient sites across the country.ResultsA total of 286 patients were included in the study. The mean age (± SD) was 61.2 ± 10.0 years with duration of diabetes of 11.64 ± 7.5 years and body mass index (BMI) of 32.1 ± 5.7 kg/m2. HbA1c before Gla-300 initiation was 9.8 ± 1.0%, and fasting plasma glucose (FPG) was 13.1 ± 3.4 mmol/L. HbA1c and FPG change from baseline to week 24 was − 1.86% (p < 0.001) and − 4.8 mmol/L (p < 0.001), respectively. The proportion of patients reaching their individualized HbA1c at week 24 was 39.1% (95% CI 33.3–45.1%), while the proportion of patients reaching their individualized HbA1c target without confirmed and/or severe hypoglycaemia was 34.8% (95% CI 29.2–40.7%). At study end, 19.0% (95% CI 14.6–24.1%) achieved HbA1c < 7%. Body weight decreased from 88.3 to 87.0 kg from baseline to week 24 with mean change of − 1.3 kg (p < 0.001). The incidence and event rates of anytime confirmed (≤ 3.9 mmol/L) and/or severe hypoglycaemia were low: 7.7% and 0.42 events per patient-year, respectively. The overall Insulin Treatment Satisfaction Questionnaire (ITSQ) score increased from 53.2 to 78.2 from baseline to week 24 and the difference of 25.1 ± 21.5 points was significant (p < 0.001).ConclusionsIn real-life settings, Gla-300 significantly improved glycaemic control and insulin treatment satisfaction in people with T2D who were inadequately controlled with NPH ± prandial insulin or premixed insulin analogues. Improvement of glycaemic control was associated with a very low risk of hypoglycaemia and with significant weight loss irrespective of the previous insulin regimen. Video Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01022-0.

Effectiveness and Safety of Switching Rapid-Acting Insulins to Insulin Glulisine in Patients with Diabetes: The Observational IGLU-S Study.

IntroductionThe IGLU-S study assessed the effectiveness of insulin glulisine after switching from human insulin/other rapid-acting insulin analogues in patients with type 1 diabetes (T1DM) and type 2 diabetes (T2DM) in a real-world setting in Germany.MethodsOpen-label, prospective, multicentre, non-interventional study in Germany. The primary outcome was proportion of patients reaching pre-defined glycosylated haemoglobin A1c (HbA1c) goal at 3, 6, 9 and 12 months. Secondary outcomes included absolute changes in HbA1c, rate of hypoglycaemia and 7-point blood glucose profiles.ResultsOverall, 432 (55 T1DM, 377 T2DM) patients were enrolled. Baseline HbA1c was 8.2% (T1DM) and 8.3% (T2DM); individual HbA1c targets were 6.8% and 6.9%, respectively. After insulin glulisine introduction, the proportion of patients achieving their individual HbA1c increased to 43.6% (T1DM) and 39.6% (T2DM) of patients at 12 months. At 12 months, mean HbA1c was reduced by 0.86 ± 1.03% (p < 0.0001) in T1DM and 1.01 ± 1.02 (p < 0.0001) in T2DM. The 7-point blood glucose profile showed a significant reduction in patients with T2DM (p< 0.0001) and a non-significant reduction in T1DM patients. Confirmed symptomatic hypoglycaemia was 5.7% (T1DM) and 1.6% (T2DM). There were no cases of severe hypoglycaemia.ConclusionSwitching prandial insulin to insulin glulisine resulted in improved effectiveness with 43.6% of T1DM and 39.6% of T2DM patients reaching their individual pre-defined HbA1c target within 1 year. Switching was safe and was associated with a low rate of hypoglycaemia and adverse events.Trial Registrationhttps://awbdb.bfarm.de; Identifier: 6818; Date of registration: 23.06.2016Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-00999-y.

Effectiveness and Safety of Insulin Glulisine When Initiating Supplementary Prandial Insulin Treatment (SIT) in Insulin-Naïve Patients with Type 2 Diabetes: The Observational IGLU-SIT Study.

IntroductionThe IGLU-SIT study documented the effectiveness of initiating supplementary prandial insulin treatment (SIT) with insulin glulisine after failure of oral antidiabetic drugs alone in patients with type 2 diabetes (T2DM) in a real-world setting in Germany.MethodsThe IGLU-SIT study was an open-label, prospective, multicentre, non-interventional study with an observation period of 12 ± 1 months. The primary objective was to determine the proportion of patients reaching their pre-defined glycosylated haemoglobin (HbA1c) goal at 3, 6, 9 and 12 months. Selected secondary objectives were absolute change in HbA1c, a 7-point blood glucose profile, and rate of hypoglycaemia. Data were evaluated overall and by age group (< 65, 65–74 and ≥ 75 years).ResultsOverall, 215 patients with T2DM were observed in 64 centres. Baseline HbA1c was 8.3%, and mean HbA1c target was 6.8% (baseline 8.1% and target 6.9% in patients ≥ 75 years). Individual HbA1c target attainment in patients peaked at 38.9% (95% confidence interval [CI] 32.1–46.1%) after 12 months; this was 45.9% in patients aged ≥ 75 years. The mean HbA1c reduction was 1.12 ± 1.05% (p < 0.0001) with only minor differences by age group. A 7-point blood glucose profile revealed significant reductions (p < 0.0001) at all time-points. The rate of confirmed symptomatic hypoglycaemia was 2.2% (95% CI 0.7–5.1) during the 12-month follow-up; rates were increased in patients aged ≥ 75 years (7.0%; 95% CI 1.5–19.1) as were the rates of adverse events (17.8 vs. 6.1%).ConclusionInitiating SIT with insulin glulisine is an appropriate treatment option in patients whose T2DM is insufficiently controlled. Particular attention should be paid to elderly patients in whom higher attainment rates of treatment target were associated with adverse events.Trial Registrationhttps://awbdb.bfarm.de; Identifier: 6819; Date of registration: 23.06.2016