Baseline FPG Research Articles

Incidence of diabetes and influencing factors in HIV-infected individuals after antiretroviral therapy in Dehong Dai and Jingpo Autonomous Prefecture

Objective: To understand the incidence of diabetes and influencing factors, the trend of FPG change and risk for mortality in HIV-infected individuals after antiretroviral therapy (ART) in Dehong Dai and Jingpo Autonomous Prefecture (Dehong). Methods: The HIV/AIDS treatment database was collected from China Information System for Disease Control and Prevention. This retrospective cohort study was conducted in HIV-infected individuals with access to ART in Dehong during 2004-2020.The Cox proportional hazard regression model was used to analyze the incidence density of diabetes, the influencing factors and risk for mortality in HIV-infected individuals with access to ART, mixed linear effects model was used to analyze the trend of FPG change and predict FPG in those with different glucose metabolic status at baseline survey. Statistical analysis was performed using software SAS 9.4. Results: A total of 8 763 HIV-infected individuals were included, in whom 8 432 (96.2%) had no diabetes, 331 had diabetes. The incidence density of diabetes was 2.31/1 000 person years. Multivariate Cox proportional hazard regression analysis revealed that 30- 59 years old, BMI ≥24.0 kg/m2, Efavirenz (EFV) based initial treatment regimen and impaired fasting glucose (IFG) at baseline survey were significantly and positively associated with incidence of diabetes. Mixed effect model revealed that FPG was positively correlated with the duration of ART, age and baseline FPG. Suffering from diabetes was a risk factor for mortality in HIV-infected individuals both at baseline survey and during follow-up. Conclusions: The risk for diabetes increased in HIV-infected individuals who were 30-59 years old, baseline BMI ≥24.0 kg/m2, received EFV based initial treatment, and IFG in HIV-infected individuals after antiretroviral therapy in Dehong, 2004-2020. It is important to pay close attention to their blood glucose, and patients with high blood glucose should receive treatment as early as possible.

ODP173 Control of Alpelisib-Induced Hyperglycemia With DPP4- Inhibitors as add on to Metformin and Insulin

Abstract Context Alpelisib is an oral phosphatidylinositol-3-kinase alpha (PI3Ka) inhibitor approved in 2019 for treatment of ER/PR+, HER2-negative advanced breast cancer. The main side effect of PI3Ka inhibition is hyperglycemia. Case A 38 year-old woman was started on alpelisib and fulvestrant therapy for Stage IV bilateral breast carcinoma (ER+, PR+, HER2-negative) with multiple distant metastases. She had previously received multiple courses of systemic therapy with palbociclib, letrozole, and everolimus, in combination with fulvestrant. She was lean (BMI 20.6 kg/m 2), had a prior history of GDM only requiring diet control, and pre-existing pre-diabetes, with a baseline FPG of 5.6 mmol/L and HbA1c of 5.9%. She developed hyperglycemia after 2 months of Alpelisib 200 mg OD (FPG 138.6 mg/dL; HbA1c 5.8%) and was started on metformin 500 mg BD. Glucose levels remained under control (fasting BG of 108-126 mg/dL) until alpelisib dose was increased to 300 mg OD. Within 6 weeks of dose increment, her fasting BG markedly increased to 324 mg/dL and HbA1c to 10%. Metformin dose was increased to 1000 mg BD, linagliptin 5 mg OD and isophane insulin at 8 units once daily, was introduced in addition to lifestyle modifications. Due to the side effects resulting in diarrhea, alpelisib was discontinued temporarily for 3 weeks before subsequent reintroduction and titration to a maximum tolerable dose of 200 mg OD. Glycemic control subsequently improved with metformin, linagliptin and titration of insulin to 14units daily, with HbA1c reduction to 6. 0% and fasting BG of 84.6 mg/dL, without any hypoglycemia. Oncological assessment showed disease response, with smaller primary tumour and stable metastatic lesions. Discussion The PI3K/AKT pathway plays a central role in cellular growth and glucose metabolism. This pathway is a potent target of anticancer therapy. In physiological glucose homeostasis, postprandial insulin secretion activates the PI3Ka pathway, subsequently upregulating glucose transporters for cellular uptake and utilization of glucose. In the phase III clinical trial (SOLAR-1), the incidence of alpelisib-induced hyperglycemia was 63.7%, and was treated with insulin sensitizers such as metformin and pioglitazone. Subsequent case series have reported effective glycemic control using very low calorie diet (VLCD), SGLT2-inhibitors and insulin therapy 1 . In our patient, linagliptin, was chosen as an adjunct therapy in addition to metformin due to its mechanism of action that address insulin resistance and favourable safety profile. We also note that the severity of alpelisib side effects appeared to be dose-dependent, as seen in the clinical trial. Conclusion We demonstrated effective control of alpelisib-induced hyperglycemia using DPP4-inhibitors as an option, in combination with metformin and insulin.

Glycemic variability and all-cause mortality in a large prospective southern European cohort of patients with differences in glycemic status.

Few studies have analyzed the relationship between glucose variability (GV) and adverse health outcomes in patients with differences in glycemic status. The present study tests the hypothesis that GV predicts all-cause mortality regardless of glycemic status after simple adjustment (age and sex) and full adjustment (age, sex, cardiovascular disease, hypertension, use of aspirin, statins, GLP-1 receptor agonists, SGLT-2 inhibitors and DPP-4 inhibitors, baseline FPG and average HbA1c). Prospective cohort study with 795 normoglycemic patients, 233 patients with prediabetes, and 4,102 patients with type 2 diabetes. GV was measured using the coefficient of variation of fasting plasma glucose (CV-FPG) over 12 years of follow-up. The outcome measure was all-cause mortality. A total of 1,223 patients (657 men, 566 women) died after a median of 9.8 years of follow-up, with an all-cause mortality rate of 23.35/1,000 person-years. In prediabetes or T2DM patients, the fourth quartile of CV-FPG exerted a significant effect on all-cause mortality after simple and full adjustment. A sensitivity analysis excluding participants who died during the first year of follow-up revealed the following results for the highest quartile in the fully adjusted model: overall, HR (95%CI) = 1.54 (1.26-1.89); dysglycemia (prediabetes and T2DM), HR = 1.41 (1.15-1.73); T2DM, HR = 1.36 (1.10-1.67). We found CV-FPG to be useful for measurement of GV. It could also be used for the prognostic stratification of patients with dysglycemia.

Combined effects of bisphenol A and diabetes genetic risk score on incident type 2 diabetes: A nested case-control study

Observational studies reported inconsistent results on the association between bisphenol A (BPA) and type 2 diabetes (T2D) risk. Whether genetic factors modified the association remains unclear. The present nested case-control study prospectively investigated the association of BPA with T2D risk, and the interaction and combined effects of diabetes genetic risk score (GRS) and serum BPA on T2D risk. Based on the Dongfeng-Tongji cohort study, 995 incident diabetes cases and 1:1 age- and gender-matched controls were included. T2D was diagnosed based on the American Diabetes Association criteria. Serum BPA concentration was measured at baseline. Diabetes GRS was constructed by 88 diabetes-related SNPs selected from large-scale GWASs. A U-shaped association was observed between serum BPA levels and T2D risk, with the lowest odds of T2D at the serum BPA levels of 1.00 ng/mL (P = 0.001 for nonlinearity). Compared with the middle group, the multivariate-adjusted ORs of T2D in the lowest group and the highest group of serum BPA were 1.52 (95% CI: 1.04, 2.22) and 1.40 (95% CI: 1.08, 1.81), respectively. Both serum BPA levels (β = 0.107, P = 0.001) and weighted-GRS (w-GRS) (β = 0.072, P = 0.02) were significantly associated with baseline FPG levels. Participants with both highest w-GRS and serum BPA levels had highest risk of T2D (OR = 2.53, 95%CI: 1.49, 4.31, P = 0.001) and higher baseline FPG levels (β = 0.218, P = 0.01), compared with those with both lowest w-GRS and serum BPA levels. Non modified effects of serum BPA levels and w-GRS on T2D, baseline FPG levels, and 5-y changes of FPG levels were detected (All Pinteraction > 0.05). Our results suggested a U-shaped association between serum BPA levels and T2D risk. Participants with higher serum BPA levels and diabetes genetic risk had higher FPG levels and higher risk of T2D.

64-LB: Long-Term Effectiveness of the My Dose Coach Application on the Maintenance of Glycemic Control in Patients with Type 2 Diabetes Mellitus in Uncontrolled

Introduction: My Dose Coach (MDC) is an app designed for basal insulin dose titration that has demonstrated its versatility in several clinical studies. We evaluated its effect on the maintenance of glycemic control for 28 weeks in patients with type 2 Diabetes. Objective: Compare the efficacy of 2 basal insulin titration strategies: MDC vs. Conventional Titration (CT) to maintain glycemic control (HbA1c < 7% and fasting plasma glucose -FPG- between 90-130 mg/dL) . Research Design and Methods: We design controlled and randomized clinical trial lasting 28 weeks, we included 80 patients with uncontrolled type 2 Diabetes (HbA1c between 8-10%) and without previous treatment with insulin. They were randomized into 2 groups: online insulin dose titration using the MDC app vs. CT in person every 2 weeks. At week 25, all enrolled patients titrated their dose in a conventional manner to assess the effect of discontinuing use of the app. Results: We included 40 patients per group, with a mean age of 52.7 years and a duration of type 2 Diabetes of 8.1 years. A total of 36 subjects (90%) vs. 33 (82.5%) completed the study, p 0.215. In the initial evaluation the following results were obtained: baseline FPG 172 vs. 167 mg/dL, p 0.98, HbA1c 9 vs. 8.9%, p 0.497, initial dose of insulin Glargine (U-100/U-300) 16.9 vs. 17.6 IU, p 0.122, MDC vs. CT respectively. Evaluation at 24 weeks, glucose 106 vs. 110 mg/dL, p 0.69, HbA1c 6.87 vs. 7.08 %, p 0.016, mean HbA1c reduction -2.10 vs. -1.83 %, p 0.015. Final insulin dose 29.9 vs. 34.1 IU, p 0.004, mean time to FPG goal 18 vs. 26 days, p 0.001. When suspending the titration by means of the application in the week 25 to 28 average glucose increased 138.5 vs. 142 mg/dL p 0.605, MDC vs. CT respectively. Conclusions: My Dose Coach app is an effective digital insulin glargine titration tool in real-world patients with uncontrolled type 2 Diabetes, as the number of participants achieving established control goals was higher and lasted longer. Fulfilling the objective of the study with lower doses of insulin and achieving stability in FPG in a considerably shorter time. Disclosure M. A. Polanco: None.

725-P: Low Fasting Glucose and Insulin Deficiency Were Related with Superiority of Insulin Degludec/Aspart Compared with Basal Insulin in Patients with Type 2 Diabetes

Objective: In spite of expected benefit of insulin degludec/aspart (IDegAsp), efficacy of once-daily IDegAsp compared to basal insulin has not been established. We searched for clinical factors associated with efficacy of once-daily IDegAsp. Methods: We collected medical records of adults with type 2 diabetes under basal insulin of 3 hospitals. From the basal insulin cohort, patients were enrolled who switched to once-daily IDegAsp and continued over 6 months. Those who maintained basal insulin were selected as a control group, by Propensity-score matching with HbA1c, insulin doses, etc. Results: The basal insulin cohort was comprised of 324 patients, and the IDegAsp group and the control were 87 patients, respectively. Baseline clinical variables and HbA1c were comparable between two groups (8.7±0.9 vs. 8.6±0.9%). After 6 months with comparable changes in insulin doses, HbA1c in the IDegAsp group was lower than that in the control (8.1±1.0 vs. 8.4±1.1%, p=0.029). With the comparable HbA1c, baseline FPG was lower in the IDegAsp (124±38 vs. 148±51 mg/dL, p<0.001). A regression analysis between FPG and HbA1c in the basal insulin cohort revealed that most participants in the IDegAsp group had lower FPG than predicted from their HbA1c. Then subgroup analysis was done according to the difference (ΔFPG) between measured FPG and predicted FPG. When compared to each control group further matched for baseline FPG, the favorable effects of IDegAsp on the reduction of HbA1c changes was significant only in the subgroup where measured FPG was severely lower than predicted FPG (98±19 vs. 140±11 mg/dL). ΔFPG was significantly correlated with fasting C-peptide (r=0.19) and glucose increment at postprandial 2 hours (r=-0.514). Conclusion: Once-daily IDegAsp was effective than basal insulin on reduction of HbA1c in patients with lower FPG than predicted from their HbA1c, which suggested severe insulin deficiency and marked postprandial hyperglycemia. Disclosure H. Jang: None. Y. Yang: None. T. Oh: None. B. Koo: None. S. Lee: None. H. Jung: Research Support; Self; Novo Nordisk. Funding National Research Foundation of Korea (2019R1A2C1007397); Korean Diabetes Association (2019F-10)

897-P: Demographic and Glycemic Parameters in Global Populations of Younger vs. Older Youth with T2D Randomized in Clinical Trials of Sitagliptin

Objectives: To compare the characteristics of younger (Y, 10-14 yrs) vs. older (O, 15-17 yrs) patients (pts) with T2D in global clinical trials of sitagliptin as initial oral therapy (IOT, NCT01485614) or as add-on to metformin therapy (AMT, NCT01472367, NCT01760447). Methods: Demographic and baseline glycemic parameters were summarized by age group for pts in the studies (Table). Results: The proportion of females was higher in Y groups and that of Whites greater in O groups. All groups had similar BMI percentiles, despite the Y group being shorter, with lower weight and BMI. Duration of T2D was similar across age groups in the IOT study, but duration was less in Y vs. O in AMT studies. Baseline A1C and FPG were comparable across age groups within a study type. Conclusions: The female preponderance reported in youth with T2D (e.g., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3038479/) was more apparent in Y groups; it is possible that the proportion of females is lower in O groups, approaching the situation in adults where sex distribution is uniform. Both Y and O pts had similar BMI percentiles. While glycemic parameters were similar across age groups within a study type, duration of diabetes was less in Y pts in AMT studies, suggesting that the need for an additional antihyperglycemic agent may occur sooner in pts diagnosed at a younger age. Disclosure R. S. Newfield: Consultant; Self; Merck Sharp & Dohme Corp. Z. Xu: Employee; Self; Merck & Co., Inc., Stock/Shareholder; Self; Merck & Co., Inc. L. W. Scherer: Employee; Self; Merck & Co., Inc., Stock/Shareholder; Self; Merck & Co., Inc. S. S. Engel: Employee; Self; Merck & Co., Inc., Stock/Shareholder; Self; Merck & Co., Inc. K. D. Kaufman: Employee; Self; Merck & Co., Inc., Stock/Shareholder; Self; Merck & Co., Inc. P. Zeitler: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly and Company, Janssen Research & Development, LLC, Merck & Co., Inc. R. Shankar: Employee; Self; AstraZeneca, Merck Sharp & Dohme Corp. A. Deeb: None. M. Y. Jalaludin: Advisory Panel; Self; Novo Nordisk, Research Support; Self; Novo Nordisk. R. Garcia: None. Y. Samoilova: None. C. A. Rosario: None. N. Shehadeh: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk, Sanofi, Research Support; Self; Novo Nordisk, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk, Sanofi. C. K. Saha: None. Y. Zhang: Employee; Self; Merck & Co., Inc., Stock/Shareholder; Self; Merck & Co., Inc. Funding Merck & Co., Inc.

An observational study evaluating effectiveness and therapeutic adherence in patients with Type 2 Diabetes initiating dulaglutide vs. subcutaneous semaglutide in Spain

AimsTo evaluate in a real-world setting the effectiveness and adherence of weekly Dulaglutide and subcutaneous (sc) Semaglutide in patients with Type 2 Diabetes Mellitus (T2DM). MethodsSingle-centre retrospective observational study comparing glucose reduction (change from baseline of Fasting Plasma Glucose – FPG, and HbA1c) and weight reduction (absolute change in weight from baseline and % weight reduction) in patients initiating Dulaglutide (n=183) or sc Semaglutide (n=115) during an index period of 18 months. Safety, adherence to and persistence on index drug were also evaluated. ResultsPatients initiating Dulaglutide were older, had a longer diabetes duration and higher baseline FPG (180 vs. 165 mg/dl) and HbA1c (8.2 vs 7.84%) and were prescribed more insulin and sulfonylurea and less SGLT-2 inhibitors vs. patients on sc Semaglutide. After a median follow-up period of 9.37 months, both drugs reduced FPG by 43.18 mg/dl (Dulaglutide) and 48.36 mg/dl (sc Semaglutide); and HbA1c by 1.03% and 1.36%, respectively. Both drugs were associated to a weight loss of 5.63 kg (5.83% baseline weight) (Dulaglutide) and 7.6 kg (7.56%) (sc Semaglutide). Baseline age, duration of diabetes, BMI and HbA1c significantly influenced outcomes. Therapeutic adherence and persistence were similar for both drugs. Up to 95% of patients on Dulaglutide used 1.5 mg dose and 72% of patients on sc Semaglutide used 1.0 mg dose. ConclusionsIn a pragmatic setting and acknowledging important differences in baseline characteristics and background antidiabetic therapy that might drive specific drug prescription, both Dulaglutide and sc Semaglutide confirm a robust effect on glucose and weight reduction with a similar therapeutic adherence.

The effects of ertugliflozin on β-cell function: Pooled analysis from four phase 3 randomized controlled studies.

To identify potential predictors and mediators of changes in β-cell function in response to ertugliflozin treatment in people with type 2 diabetes mellitus (T2DM). Data from patients with T2DM randomized to ertugliflozin (5 or 15 mg; observations from both doses were pooled) or placebo in four phase 3 clinical studies (clinicaltrials.gov: NCT01958671, NCT02226003, NCT02036515, NCT02099110) were pooled and analysed. Change from baseline in β-cell function at week 26 was assessed, and its potential predictors and mediators were analysed using linear and multiple regression analyses. Compared with placebo, ertugliflozin improved β-cell function when assessed by mean percent change from baseline in homeostatic model assessment of β-cell function (HOMA-%β; ertugliflozin: 14.7%, 95% confidence interval [CI] 12.3, 17.1; placebo: -0.4%, 95% CI -3.4, 2.5], but not when assessed by change in C-peptide index following a mixed meal tolerance test. Change in HOMA-%β correlated with change from baseline in glycated haemoglobin (HbA1c) and treatment with ertugliflozin, and weakly with change from baseline in body weight. In the ertugliflozin group, change in HOMA-%β correlated with baseline fasting plasma glucose (FPG; r = 0.235, P < 0.001), baseline HbA1c (r = 0.138, P < 0.001), baseline homeostatic model assessment of insulin resistance (HOMA-IR; r = 0.162, P < 0.01), and baseline HOMA-%β (r = -0.321, P < 0.001) in linear regression analyses. Multiple regression analyses yielded similar results. In people with T2DM, ertugliflozin treatment improved fasting β-cell function, but no effect on postprandial β-cell function was observed in this analysis. Improvement in HOMA-%β was predicted by high baseline FPG, HbA1c, HOMA-IR, and low baseline HOMA-%β, and mediated by ertugliflozin treatment, and improved HbA1c and body weight.

Indirect comparison of efficacy and safety of insulin glargine/lixisenatide and insulin degludec/insulin aspart in type 2 diabetes patients not controlled on basal insulin

BackgroundFixed-dose combinations of insulin glargine/lixisenatide (IGlarLixi) or insulin degludec/insulin aspart (IDegAsp) constitute treatment intensification in type 2 diabetes mellitus (T2D). ObjectivesCompare efficacy and safety of IGlarLixi and IDegAsp (as intensification from basal insulin), by indirect comparison of phase III trials, in the absence of head-to-head trials. Study eligibility criteriaStudies comparing treatment intensification by once-daily IDegAsp or IGlarLixi to basal insulin. Data were extracted from two trials (BOOST: Intensify-Basal and LixiLan-L) retained for analysis. Synthesis methodsTreatments were compared in terms of estimated treatment difference (ETD) in glycated haemoglobin (HbA1c), fasting and postprandial plasma glucose (FPG and PPG) change from baseline; in addition to hypoglycaemia incidence and weight changes. ResultsIn a fixed-effect model examining HbA1c control, IGlarLixi was more effective than IDegAsp in reducing HbA1c (ETD 0.53%, P<0.0001]), PPG (ETD 2.65%, P<0.0001), and body weight (ETD 1.73kg, P<0.0001). Patients on IGlarLixi were more likely to achieve HbA1c<7% than patients on IDegAsp (odds ratio [OR]=0.40, P<0.0001), with lower incidence of hypoglycaemia (OR=1.33, P<0.001). LimitationsLimited number of studies; different baseline HbA1c and FPG. ConclusionOnce-daily IGlarLixi is more efficient than once-daily IDegAsp in controlling HbA1c and PPG and associates with greater weight loss and lower hypoglycaemia incidence.

Abdominal aorta diameter as a novel marker of diabetes incidence risk in elderly women

The prevalence of diabetes mellitus is increasing worldwide, including the nation of Poland. The aim of this prospective and observational study was to determine risk factors and the predictors of diabetes incidence in elderly women, and to calculate the diabetes incidence ratio in this population. Two-hundred women, aged 65–74, who were non-diabetic at baseline in 2012 were followed for 6.5 years. All women were checked for incident diabetes. In non-diabetic subjects, diagnostic procedures for diabetes were performed according to Poland’s Diabetes recommendations. Between April 2012 and September 2018, 25 women developed diabetes and the next 11 cases were diagnosed based on FPG or oral glucose tolerance test. Women with incident diabetes had significantly higher baseline FPG, triglycerides (TG), TG/HDL cholesterol ratio and visceral adiposity index (VAI) score, and lower abdominal aorta diameter (AAD), HDL cholesterol and eGFR. In the Cox proportional hazard regression analysis, only AAD < 18 mm and VAI score ≥ 3.8 were independently associated with diabetes risk, hazard ratio (HR) 2.47 (95% confidence interval 1.21–5.02), P = 0.013 and HR 2.83 (1.35–5.94), P = 0.006 respectively. In the backward stepwise regression analysis including all variables, diabetes incidence could be predicted from a linear combination of the independent variables: AAD < 18 mm (P = 0.002), VAI score ≥ 3.8 (P < 0.001) and FPG ≥ 5.6 mmol/L (P = 0.011). The calculated incidence of diabetes was 2769.2 new cases/100,000 persons per year. AAD below 18 mm seem to be a novel, independent marker of diabetes risk in elderly women, and AAD assessment during routine abdomen ultrasound may be helpful in identifying females at early elderliness with high risk of diabetes incidence.

1582-P: Glycemic Change from Baseline in the First Large-Scale Longitudinal Nationwide Study on Management and Real-World Outcomes of Diabetes in India (LANDMARC)

Glycemic change from baseline to 6-months was examined across various subgroups during first 6-months observational period in this 3 year prospective study (LANDMARC; CTRI/2017/05/008452). Descriptive statistics was used to assess glycemic trends in adults with T2D controlled/uncontrolled on ≥2 antihyperglycemic medications. Of 6236 enrolled participants, 5703 completed 6-month follow-up (visit 2 [V2]). A significant (p&amp;lt;0.0001) decrease in all glycemic parameters was noted at V2 from mean (SD) baseline A1C (8.05% [1.59]), FPG (142.80 [50.35]) mg/dL, and PPG (205.70 [72.26]) mg/dL; however, only 18.9% had reached optimum glycemic control (A1C&amp;lt;7%) (Table). On A1C subgroup stratification, significant reduction in number of participants was seen in 8-8.9% and ≥9% groups with more participants entering the 7-7.9% group (Table). In the CV risk factor and complications subgroups, glycemic parameters worsened in participants with family history of coronary disease and history of stroke. Interestingly, only participants with heart failure had optimal glycemic control and showed maximum reduction in FPG and PPG (Table). Within 6 months of study initiation, there was a marked improvement in the glycemic parameters in people with T2D; however notably only few had reached optimum control levels. Disclosure R. Ghosh: Employee; Self; Sanofi. A.K. Das: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. A. Mithal: Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Johnson &amp; Johnson, Lilly Diabetes, Novo Nordisk A/S. S. Joshi: Advisory Panel; Self; Novo Nordisk A/S, Roche Pharma, Sanofi. K. Kumar: None. S. Kalra: Advisory Panel; Self; Eli Lilly and Company. Speaker’s Bureau; Self; Novo Nordisk A/S, Sanofi-Aventis. A. Unnikrishnan: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; Eli Lilly and Company, Ipca Laboratories, Merck Sharp &amp; Dohme Corp., Novartis AG. H. Thacker: None. B. Sethi: None. S. Mohanasundaram: Employee; Self; Sanofi. S.K. Menon: None. A. Nair: Employee; Self; Sanofi. N. Rais: None. S. Wangnoo: None. S. Chowdhury: Advisory Panel; Self; Novo Nordisk A/S. A.H. Zargar: None. Funding Sanofi India Limited

2139-PUB: Antihypertensive Effect of Azilsartan in Newly Diagnosed Stage 2 Diabetic Hypertensives

Background and Aim: Coexistence of hypertension (HTN) and type 2 diabetes (T2DM) multiplies the risk of cardiovascular events. Early identification and prompt management of elevated blood pressure in T2DM has shown to improve the quality of life and to reduce the economic burden to the patients. We studied blood pressure (BP) lowering effect of Azilsartan (AZST) monotherapy in newly diagnosed stage 2 hypertensives with a history of T2DM. We also analysed its effects on blood glucose and renal indices. Methods: T2DM Subjects attending a specialized diabetes clinic, who were diagnosed with HTN for the first time, were invited to participate. Mean of 3 BP readings was considered for analysis after due consent. Subjects with stage 2 hypertension were administered AZST 40mg once daily. After 3 months they had a repeat BP recording. Subjects underwent serum creatinine, Na+, K+, fasting (FPG) and postprandrial (PPG) plasma glucose measurements at baseline and after 3moths’ of enrolment. We compared BP lowering efficacy and changes in plasma glucose and renal parameters at baseline and after 3months of AZST therapy. Diabetic, dyslipidemic and other chronic medicines were continued unchanged during the study period. Results: Inclusion criteria were met by 474 subjects (117, 25% females). Mean age and duration of diabetes were 53.3 (95% CI 52.3-54.3) and 7.03 (CI 6.6-7.5) years respectively. With AZST therapy mean SBP dropped from 152.7 (CI 151.1-154.3) mm Hg to 136.4 (CI 134.9-138.0) mm Hg (p &amp;lt;0.05) and the post treatment DBP declined to 79.6 (CI 78.8-80.4) mm Hg from its baseline value of 90.5 (CI 89.6-91.4) mm Hg (p &amp;lt;0.05). The mean baseline FPG and PPG were 158.8 (CI 154.0-163.4) mg/dL and 237.3 (CI 231.9-242.7) mg/dL in order. There was a non-significant decline in plasma glucose, but no changes were seen in eGFR or electrolytes. No adverse event was reported. Conclusion: Azilsartan monotherapy was found to be safe and effective in managing newly diagnosed stage 2 hypertension in type 2 diabetes without hampering renal function. Disclosure H. Mahapatra: None. M. Khuntia: None. S. Mishra: None. S.K. Mishra: None. R.K. Padhi: None. B. Jena: None. S. Das: None. R.K. Khatua: None. A.R. Jena: None. R. Mahapatra: None. L. Mahapatra: None. A.K. Sahoo: None. Funding Jyoti Diabetes Research Foundation

A prospective open labelled study of effect of vildagliptin with metformin in patients with type 2 diabetes mellitus

Background: The pathophysiology of Type 2 Diabetes Mellitus (T2DM) is characterized by deficient insulin activity arising from decreased insulin secretion secondary to beta cell failure, and/or compromised insulin action in peripheral target tissues (insulin resistance).Methods: The patients attending the medicine outpatient department of tertiary care teaching hospital were enrolled in the study. Patients, who fulfilled the selection criteria, were allocated in two treatment groups. Group A was treated with metformin (Sustained release preparation) 500mg once daily and group B was treated with vildagliptin 50mg once daily. Measurement of body weight, fasting blood glucose (FPG), postprandial blood glucose (PPG), glycated haemoglobin (HbA1c), serum urea, creatinine and urine albumin/creatinine ratio was performed at the initial visit and at the end of 12 weeks of treatment.Results: Out of 84 patients screened, 74 were enrolled for the study. Of the 74 patients, 39(52.7%) were male and 35(47.3%) were female. The patients were divided into two groups (group A and group B) consisting 37 patients in each group. Out of 74 patients, 62 completed the study. Out of 12 patients who did not complete the study, 5 patients were lost during follow-up period and 7 patients discontinued treatment due to AEs. The mean age of the patients was 51 and 49years in the groups A and B respectively. There was no statistical difference in the baseline FPG, PPG, HbA1c, serum urea, serum creatinine, urine ACR and body weight between two groups.Conclusions: The study shows that metformin and vildagliptin have similar effect on glycaemic control, but vildagliptin exerts better Reno protective effect and there were no reports of serious adverse events.

Prevalence and related factors on diabetes among HIV/AIDS receiving antiretroviral therapy in Dehong Dai and Jingpo Autonomous Prefecture

Objective: To study the prevalence and correlates of diabetes among HIV/AIDS who were on antiretroviral therapy (ART) in Dehong Dai and Jingpo autonomous prefectures (Dehong), Yunnan province. Methods: The database of HIV/AIDS receiving ART in Dehong was downloaded by using the basic information system of AIDS prevention and control in China. In this cross-sectional study, HIV/AIDS patients who were currently on ART and aged 18 years or above, were consecutively recruited, between July 2017 and June 2018, in Dehong. All the subjects underwent hemoglobin A1c (HbA1c) testing. Patient with diabetes was defined as meeting any of these indicators (HbA1c ≥6.5%, baseline FPG ≥7.0 mmol/L, FPG ≥7.0 mmol/L in the most recent visit). Both univariate and multivariate logistic regression analysis were carried on to evaluate the correlates of diabetes among the HIV/AIDS patients. Results: In total of 4 376 HIV/AIDS patients were included for analysis, with the average age as (43.7±10.1) years, proportion of males as 53.8% (2 356/4 376) and the HCV positive rate as 24.1% (1 055/4 376). The mean years was (8.9±3.8) years after the HIV diagnosis was made, and the mean duration on treatment was (6.8±2.9) years. The prevalence of diabetes was 11.4% (500/4 376). Through multivariate logistic regression analysis, data showed that the risk factors of diabetes of HIV/AIDS on ART were: aged 40 years or above, being male, HCV positive, baseline body mass index ≥24.0 kg/m(2), elevated TG ≥1.70 mmol/L in the most recent visit and baseline antiretroviral regimens under Efavirenz (EFV). Conclusions: Prevalence rate of diabetes appeared higher in HIV/AIDS patients who were on ART in Dehong. Prevention and control measures should be targeted on HIV/AIDS patients who were with risk factors of diabetes as being elderly, male, HCV positive, overweight and higher TG. Further esearch is needed to evaluate the association between the use of EFV and diabetes.

1232-P: Predictors of ß-Cell Function Changes: Pooled Analysis from Phase 3 Ertugliflozin Studies

Improving glycemic control generally improves β-cell function in T2DM but the predictors for this effect are unclear. SGLT2 inhibitors improve glycemia and have no known direct effects on β-cell function. Therefore, we aimed to identify predictors of β-cell function changes by treatment with the SGLT2 inhibitor ertugliflozin (ERTU). Data of patients (pts) randomized to ERTU (5 or 15 mg) only or placebo (PBO) only from four phase 3 ERTU studies of the VERTIS clinical program were pooled and analyzed. Change from baseline in β-cell function (fasting homeostatic model assessment beta [HOMA-β] and C-peptide Insulinogenic Index [IGI] at 30 min of a mixed meal tolerance test) at Week 26 was assessed, followed by linear regression analyses to examine the relationship between change in β-cell function versus metabolic and demographic characteristics. ERTU compared with PBO improved β-cell function when assessed by the changes from baseline (95% CIs) in HOMA-β (14.7 [12.3,17.1] versus −0.4 [−3.4, 2.5]) but not IGI. Change in HOMA-β correlated negatively and similarly with change in A1C in both groups (ERTU: r=−0.29; PBO: r=−0.36, both P&amp;lt;0.001). In the ERTU group, change in HOMA-β correlated positively with baseline fasting plasma glucose (FPG; r=0.23, P&amp;lt;0.001) and baseline A1C (r=0.14, P&amp;lt;0.001) but negatively with baseline HOMA-β (r=−0.32, P&amp;lt;0.001) in simple linear regression analyses; no significant correlations were found with age, sex, ethnicity, diabetes duration, baseline serum triglycerides, creatinine, weight or systolic blood pressure. Correlations between change in HOMA-β and baseline FPG, A1C and HOMA-β remained significant in multiple regression analyses. ERTU improves fasting HOMA-β but not the postprandial IGI in pts with T2DM. Pts with high baseline FPG and A1C values but low baseline HOMA-β may derive greater benefit than those with low baseline FPG, A1C and high HOMA-β with ertugliflozin treatment in terms of fasting HOMA-β. Disclosure S. Gallo: Employee; Self; Pfizer Inc. Stock/Shareholder; Self; Pfizer Inc. A. Raji: Employee; Self; Merck &amp; Co., Inc. Stock/Shareholder; Self; Merck &amp; Co., Inc. R.A. Calle: Employee; Self; Pfizer Inc. Stock/Shareholder; Self; Pfizer Inc. M.C. Ellison: Employee; Self; Merck &amp; Co., Inc. C. Meyer: Employee; Self; Merck &amp; Co., Inc. Funding Merck Sharp &amp; Dohme Corp; Pfizer Inc.

Effect of probiotic yoghurt on plasma glucose in overweight and obese pregnant women: a randomized controlled clinical trial.

There is only some evidence about effectiveness of probiotics for preventing gestational hyperglycaemia. This trial examined the effects of probiotic yoghurts containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 on maternal plasma glucose (primary outcome) and on some maternal and infant complications (secondary outcomes) in overweight and obese women with no diabetes in pregnancy. Using stratified block randomization, women with pre- or early-pregnancy BMI ≥ 25 and fasting plasma glucose < 92mg/dl at 22weeks of gestation were assigned into probiotic or conventional yoghurt group, consuming 100g/day from 24weeks of gestation until delivery. The women and their infants were followed up until 1month after birth. In each group, one out of 65 women had intra-uterine foetal death and were not analysed for other outcomes. The mean BMI was 29.2 (SD 3.3) in probiotic and 30.3 (SD 4.1) in conventional yoghurt group. Four weeks after initiation of the treatment, plasma glucose levels were significantly lower in the probiotic than in conventional yoghurt group at fasting (mean difference adjusted for the BMI category) and baseline FPG (- 4.0mg/dl; 95% confidence interval - 6.9, - 1.1) and 2-h OGTT (- 13.9; - 22.8, - 5.0). At the 1-h OGTT, however, the difference was not statistically significant (- 9.8; - 20.6, 0.9). Further, there was a significantly lower infant bilirubin level in the probiotic group on days 3-5 after birth (- 2.2mg/dl; - 3.3, - 1.2). There were not statistically significant differences between the groups regarding the risk of gestational diabetes (6 vs 11; odds ratio 0.5; 0.2, 1.5), preterm delivery (3 vs 8; 0.3; 0.1, 1.2), and other maternal and infant outcomes. The probiotics supplementation has some beneficial effects on glucose metabolism of overweight and obese pregnant women. Nevertheless, further studies are required to judge the clinical significance of such effects.

Effect of teneligliptin vs metformin on glycemic control in Indian patients with newly-diagnosed, drug-naïve type 2 diabetes mellitus: a 12-week randomized comparative clinical study

Background: This comparative study was done to evaluate the change from baseline in HbA1c levels with teneligliptin vs. metformin treatments at week 12 among recently diagnosed type 2 DM patients attending Medicine OPD of Dr. B. C. Roy Hospital, Haldia, West Bengal (a tertiary care teaching hospital).Methods: In this prospective parallel group clinical study patients were divided into two groups. Group A patients were on metformin monotherapy therapy and Group B patients were on teneligliptin monotherapy. Data of 40 patients (20 patients in each group) were available for analysis in the present study. Secondary endpoints included changes from baseline FPG and 2h-PPG values at 12 weeks were evaluated. Safety and tolerability were assessed by the incidence of adverse events (AEs) throughout the study period.Results: The mean age of patients was 50.05±12.35 years and out of the entire patient population 70% were males and 30% were females. At the end of 12 weeks or 3 months of metformin therapy, mean HbA1c, FBG, and PPG were significantly reduced by 0.52%, 16.2mg/dL, and 36.8mg/dL, respectively, and 37.75% of patients achieved the HbA1c target of &lt;7%. At the end of 12 weeks or 3 months of teneligliptin therapy, mean HbA1c, FBG, and PPG were significantly reduced by 0.60%, 19.4mg/dL, and 49.8mg/dL, respectively (Table 2), and 40% of patients achieved the HbA1c target of &lt;7%.Conclusions: Teneligliptin, a DPP4 inhibitor reduced HbA1C significantly compared with monotherapy of metformin in treatment naive patients at week 12. It also reduced FBG and 2-h PPBG as compared with metformin at week 12.

High Levels of Baseline HbA1c, FPG, and 2-Hour Postprandial Glucose Are Key Predictors for Not Achieving HbA1c &amp;lt; 7.0% at Six Months in People with T2DM Starting Insulin Glargine 100 U/mL

Pooled participant-level data from 16 RCTs (≥ 24 weeks) were used to explore the association of demographic and clinical markers with different levels of HbA1c achieved at Week 24 in insulin-naive people with T2DM on oral agents after starting insulin glargine 100 U/mL (Gla-100). A stepwise logistic regression analysis was performed to identify potential predictive and exploratory factors for attaining an HbA1c &amp;lt; 7.0%. In total, 46%, 37%, and 17% of 3,415 participants (53% male) included in the analysis achieved Week 24 HbA1c &amp;lt; 7.0%, 7.0-8.0%, and &amp;gt; 8.0%, respectively. Key clinical findings and multivariate analysis results are shown in the Table. Sex, diabetes duration, baseline BMI, HbA1c, FPG, and overall 2h-PPG were significant predictors of attaining HbA1c &amp;lt; 7.0% at Week 24, whereas change in FPG or 2h-PPG were not. FPG and 2h-PPG levels in the HbA1c &amp;gt; 8.0% group remained highest despite a higher Gla-100 dose (0.52 U/kg) and lower overall hypoglycaemia (PG &amp;lt; 3.9 mmol/L) rate at Week 24. In people with T2DM, high baseline HbA1c, FPG, and PPG levels are important predictors of failure of basal insulin/OAD therapy to achieve desired glycaemic goals. A more active treatment strategy targeting both fasting and postprandial hyperglycaemia appears to be indicated for people with poor glycaemic control after starting basal insulin therapy. Disclosure D.R. Owens: Consultant; Self; Boehringer Ingelheim GmbH, Roche Diagnostics Corporation, Eli Lilly and Company, Sanofi, Takeda Development Centre Europe Ltd.. Speaker's Bureau; Self; Boehringer Ingelheim GmbH, Roche Diagnostics Corporation, Eli Lilly and Company, Sanofi, Takeda Development Centre Europe Ltd. W. Landgraf: Employee; Self; Sanofi-Aventis Deutschland GmbH. Stock/Shareholder; Self; Sanofi. M. Zhang: Employee; Self; Sanofi US. Stock/Shareholder; Self; Sanofi US. B.M. Frier: Advisory Panel; Self; Novo Nordisk A/S, Eli Lilly and Company. Consultant; Self; Locemia Solutions, Zucara Therapeutics. Speaker's Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Roche Pharma, AstraZeneca. L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Sanofi US, Novo Nordisk Inc.. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Other Relationship; Self; American Diabetes Association. P. Home: Consultant; Self; AstraZeneca. Other Relationship; Self; Biocon, Boehringer Ingelheim GmbH. Research Support; Self; GlaxoSmithKline plc.. Consultant; Self; Hanmi Pharmaceutical. Other Relationship; Self; Janssen Research &amp; Development. Consultant; Self; Janssen Research &amp; Development, Merck &amp; Co., Inc.. Other Relationship; Self; Merck &amp; Co., Inc.. Research Support; Self; Merck &amp; Co., Inc.. Other Relationship; Self; Novo Nordisk A/S. Consultant; Self; AntriaBio, Inc., Earlysign, Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Sanofi. Consultant; Self; Sanofi. G.B. Bolli: Speaker's Bureau; Self; Menarini Group, Sanofi. Research Support; Self; Sanofi.

The Influencing Factors of Continuous Subcutaneous Insulin Infusion in Newly Diagnosed T2DM Patients

In order to investigate the influencing factors of continuous subcutaneous insulin infusion (CSII) of 48 newly diagnosed T2DM patients without hypoglycemic agents were analyzed. The enrolled patients were 46.1±9.1 years in age, with a BMI of 25.2±2.8 kg/m2, FPG of 11.6±3.2mmol/L, PPG of 17.4±6.5mmol/L, and HbA1c of 10.8±2.1%. Glucose levels and beta cell function were measured at baseline. An intravenous glucose tolerance test (IVGTT) using 25g of glucose (50ml of 50% glucose) was conducted to assess acute insulin response (AIR) as beta cell function. Serum insulin levels before and 1, 2, 4, 6, and 10 min after glucose injection were measured, and AIR was calculated as the incremental trapezoidal area. The initial insulin dosages of CSII were 0.5-0.7IU/kg according to clinical experience. The insulin dosages were adjusted to achieve euglycemia which was defined as fasting glucose between 4.4 and 6.0 mmol/L and postprandial glucose between 4.4 and 8.0mmol/L as capillary blood glucose values were measured including fasting, premeal and postprandial. CSII therapies were maintained for 14 days and fasting C peptide was measured at 7th day after achieving glycemic targets. The patients achieved glycemic control in 3(3) days. Baseline FPG, PPG, HbA1c, and HOMA-IR were positive related to the days spent to euglycemia (r=0.402, p=0.0and r=0.334, p=0.029 and r=0.352, p=0.015, and r=0.306, p=0.035, respectively). AIR was negative related (r=-0.457, p=0.001). The initial insulin dosages were not associated with the days of achieving glycemic control. The incidents of hypoglycemia of all patients were 3(3) times, which were negative related to C peptide level at 7th day after achieving euglycemia (r=-0.333, p=0.021). In conclusion, the patients with lower baseline glucose levels and better beta cell function were preferred to achieve glycemic control in shorter time during IIT. The suppression of endogenous insulin secretion was associated with exposure of hypoglycemia. Disclosure W. Ke: None. L. Liu: None. Y. Li: None.