bluuebunny/crossref_metadata_2025_split huggingface dataset:
23-LB: Lipoprotein Subfractions Are Associated with Diabetic Cardiovascular Disease and Death among 9,795 Patients in the FIELD Trial
Authors: JONES STEVEN R. , JENKINS ALICIA J. , JANUSZEWSKI ANDRZEJ S. , OCONNELL RACHEL L. , LI LIPING , SULLIVAN DAVID , TASKINEN MARJA-RIITTA , SCOTT RUSSELL , FRANCIS WATTS GERALD , BARTER PHILIP J. , SIMES R. JOHN , TOTH PETER P. , KEECH ANTHONY C. 
Published: June 2019

Background: The FIELD study, a 5-year randomized double-blind placebo-controlled trial of fenofibrate vs. placebo in 9,795 adults with type 2 diabetes (T2D), was designed to evaluate effects on coronary and cardiovascular (CV) events. In this analysis we explored associations between lipoprotein subfractions and on-study CV events and death.
Methods: We performed ultracentrifugation using the vertical auto profile (VAP, Atherotech) on plasma at baseline and after 6 weeks of fenofibrate (active run-in) exposure. Analyses were performed using Cox proportional hazards and logistic regression analysis. Results were adjusted for gender, with log transformation as necessary.
Results: Total CVD and CV death correlated negatively with HDL-C and its subfractions, as well as apoA1 and apoA2. In addition to LDL-C, small, dense LDL (LDL4-C), non-HDL-C, apo B, triglycerides, and apoC3 increased risk for total CVD. For CVD death, HDL-C and its subfractions were protective, while apo B, triglycerides, apo C3, and various VLDL-C species were associated with increased risk.
Conclusions: Detailed lipoprotein analysis identifies multiple lipoprotein subclasses and apolipoproteins and their ratios associated with acute cardiovascular events and death. Serum levels of a number of these lipoprotein and apoprotein species were improved by fenofibrate therapy.

Disclosure
S.R. Jones: None. A.J. Jenkins: Advisory Panel; Self; Abbott, Australian Diabetes Society, Medtronic. Research Support; Self; Abbott, GlySens Incorporated, Medtronic, Mylan. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk Inc. A.S. Januszewski: None. R.L. OConnell: None. L. Li: None. D. Sullivan: None. M. Taskinen: Advisory Panel; Self; Novo Nordisk A/S. Consultant; Self; Akcea Therapeutics, Chiesi USA, Inc. Research Support; Self; Amgen Inc., Novo Nordisk A/S. Speaker’s Bureau; Self; Amgen Inc. R. Scott: None. G.F. Watts: None. P.J. Barter: Advisory Panel; Self; Merck & Co., Inc., Pfizer Inc. R. Simes: None. P.P. Toth: Consultant; Self; Amarin Corporation, Amgen Inc., AstraZeneca, Kowa Pharmaceutical Europe Co. Ltd., Novo Nordisk Inc. Speaker’s Bureau; Self; Amarin Corporation, Amgen Inc., Merck & Co., Inc., Novo Nordisk Inc., Regeneron Pharmaceuticals, Sanofi US. A.C. Keech: None.
230-OR: Intramuscular Triglyceride Subcellular Localization Is Related to Insulin Sensitivity in Humans
Authors: KAHN DARCY E. , ZARINI SIMONA , PERREAULT LEIGH , NEWSOM SEAN A. , HARRISON KATHLEEN A. , BERGMAN BRYAN C. 
Published: June 2019

Intramuscular triglyceride (IMTG) content is linked to insulin resistance in humans. Similar to bioactive lipids, IMTG is localized in different compartments of skeletal muscle which may influence the impact on insulin sensitivity. Subsarcolemmal and intermyofibrillar localization of IMTG is known to alter the relationship to insulin sensitivity. However, more detailed subcellular localization of IMTG species has yet to be described. We evaluated subcellular localization of IMTG in lean (n=15), endurance trained athletes (n=16), obese (n=15), and type 2 diabetic (n=12) men and women. Muscle biopsies were fractionated into sarcolemmal, cytosolic, mitochondrial/endoplasmic reticulum, and nuclear compartments. IMTG were measured using LC/MS/MS, and insulin sensitivity using insulin clamps. Insulin sensitivity was significantly different between groups, with athletes&gt;lean&gt;obese&gt;T2D (p&lt;0.001). Most sarcolemmal IMTG species were significantly greater in obese and T2D compared to lean and athletes, but IMTG with only saturated acyl chains (C48:0, C50:0, C52:0) were significantly increased only in T2D. Sarcolemmal IMTG were inversely related to insulin sensitivity (p=0.009), and positively related to fasting insulin (p=0.004). Nuclear IMTG were significantly greater in T2D compared to lean and athletes. While there was not a significant difference in total cytosolic IMTG, saturated cytosolic IMTG species were significantly increased in T2D compared to lean and athletes, and saturated cytosolic IMTG were inversely correlated to insulin sensitivity (p=0.001). There were no significant differences between groups for IMTG concentration in the mitochondrial/ER compartment. Combined these data reveal previously unknown differences in subcellular IMTG localization, indicate the importance of sarcolemmal and nuclear IMTG to insulin sensitivity, and suggest saturated IMTG may be uniquely deleterious for muscle insulin sensitivity.

Disclosure
D.E. Kahn: None. S. Zarini: None. L. Perreault: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S. S.A. Newsom: None. K.A. Harrison: None. B.C. Bergman: Advisory Panel; Spouse/Partner; AstraZeneca, Merck & Co., Inc., Novo Nordisk Inc.

Funding
National Institutes of Health (R01DK089170, RR-00036, P30DK048520)
2301-PUB: Efficacy of HbA1c Changes, Weight Changes, and Blood Pressure Changes in GLP-1RA Daily Treatment or GLP-1RA Weekly Treatment in Type 2 Diabetes
Authors: CAI XIAOLING , YANG WENJIA , ZHANG SIMIN , JI LINONG 
Published: June 2019

Aims: To evaluate the efficacy of GLP-1 receptor agonist daily treatment or GLP-1 receptor weekly treatment in type 2 diabetes.
Methods: A systematic search of MEDLINE, Embase and Cochrane Central Register of Controlled Trials was made from the beginning date to December 2018.
Results: A total of 111 studies were included in the meta-analysis. Compared with placebo, treatment with GLP-1RA daily led to significant decrease in HbA1c from baseline (WMD, -0.78%, P&lt;0.01), significant decrease in weight (WMD, -0.97kg, P&lt;0.01), significant decrease in SBP (WMD, -2.41mmHg, P&lt;0.01). Compared with placebo, treatment with GLP-1RA weekly resulted in significant decrease in HbA1c from baseline (WMD, -1.00%, P&lt;0.01), significant decrease in weight (WMD, -1.33kg, P&lt;0.01), significant decrease in SBP (WMD, -1.41mmHg, P&lt;0.01) (Table 1).
Conclusion: Compared with placebo, in type 2 diabetes patients, treatment with GLP-1 receptor agonist daily and weekly, both resulted in significant decrease in HbA1c, weight and SBP from baseline.

Disclosure
X. Cai: None. W. Yang: None. S. Zhang: None. L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck KGaA, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Roche Pharma, Sanofi.
231-OR: ADA Presidents' Select Abstract: Pyruvate Kinase M2 Overexpression in Podocytes Ameliorates Nephropathy in Diabetic Mice
Authors: SHINJO TAKANORI , ST-LOUIS RONALD , FU JIALIN , PARK KYOUNGMIN , LI QIAN , YOKOMIZO HISASHI , YU MARC GREGORY , WANG HAIYAN , KANNT AIMO , SADOWSKI THORSTEN , KING GEORGE L. 
Published: June 2019

Elevated expression of pyruvate kinase isoform M2 (PKM2) in the renal glomeruli of people with diabetes is associated with protection from nephropathy even with hyperglycemia. Furthermore, systemic use of PKM2 activators (TEPP46) can prevent or reverse glomerular pathology in diabetic mice. To determine specifically the role of PKM2 in the development or progression of diabetic glomerulopathy, we generated transgenic mice overexpressing PKM2 specific targeted to the podocytes (PPKM2Tg mice) driven by the podocin promoter. Analysis of the glomeruli from these mice showed 1.5-fold increases in mRNA and protein levels without changes in PKM1, compared to wild type (WT) littermates (p&lt;0.05). Pyruvate kinase (PK) activity in the glomeruli of the PPKM2Tg mice was increased by 40% compared to those in WT mice (p&lt;0.05). Diabetes was induced in eight-week-old WT and PPKM2Tg mice by streptozotocin (STZ) and maintained with sustained glucose levels &gt;400mg/dL for 7 months. Diabetic PPKM2Tg mice showed significantly lower urinary albumin-creatinine ratio (ACR) and kidney weight-body weight ratios (p&lt;0.05) compared to diabetic WT mice even with similar hyperglycemia. PK activity was lowered in the glomeruli of diabetic WT mice by 30%, whereas levels in diabetic PPKM2Tg mice were comparable to nondiabetic WT mice. For renal pathology, diabetic PPKM2Tg mice exhibited smaller glomeruli compared to diabetic WT mice. Similarly, expressions of inflammatory genes including TNFα and MCP-1, and fibrotic genes including fibronectin and TGF-β1 were downregulated in the glomeruli of diabetic PPKM2Tg mice compared to diabetic WT mice. In contrast, mitochondrial genes such as PGC-1α, Opa1, and cytochrome b in the glomeruli of diabetic PPKM2Tg mice were significantly upregulated as compared to diabetic WT mice. These findings strongly suggest that upregulation or activation of PKM2 and glycolysis may improve mitochondrial function in podocytes and prevent the progression of diabetic nephropathy.

Disclosure
T. Shinjo: None. R. St-Louis: None. J. Fu: None. K. Park: None. Q. Li: None. H. Yokomizo: None. M. Yu: None. H. Wang: None. A. Kannt: Employee; Self; Sanofi. T. Sadowski: Employee; Self; Sanofi-Aventis Deutschland GmbH. G.L. King: Research Support; Self; Sanofi.

Funding
National Institutes of Health; Sanofi
2313-PUB: Efficacy by Baseline BMI with Once Weekly Dulaglutide in Chinese T2DM Patients
Authors: SHI YONGQUAN , ZHANG BIN , WU HAIYA 
Published: June 2019

Objective: To evaluate the efficacy of dulaglutide (1.5mg, 0.75mg) in Chinese T2DM patients with baseline BMI &lt;25 kg/m2 or ≥25 kg/m2, a post hoc analysis was conducted on two randomized trials at week 26.
Methods: Patients in the dulaglutide versus glimepiride study (AWARD-CHN1, NCT01644500; n=555) were treatment-naive or discontinued from oral monotherapy; those in the dulaglutide versus glargine study (AWARD-CHN2, NCT01648582; n=591) continued on metformin and/or sulfonylurea. Analyses were conducted based on mixed-model repeated measures using modified intent-to-treat analysis set with only Chinese population. HbA1change from baseline was analyzed by individual study.
Results: Overall, 45.6% of patients in AWARD-CHN1 and 42.8% in AWARD-CHN2 had a baseline BMI &lt;25 kg/m2. In patients with BMI&lt;25 kg/m2 or ≥25 kg/m2 of AWARD-CHN1, both doses of dulaglutide were superior to glimepiride for HbA1c reduction from baseline with a least squares mean difference of -0.55% or -0.53% for dulaglutide 1.5mg (both P&lt;0.001) and -0.32% or -0.35% for dulaglutide 0.75mg (both P&lt;0.05). In AWARD-CHN2, dulaglutide 1.5mg was superior to glargine for HbA1c reduction from baseline with a least squares mean difference of -0.58% or -0.55% in patients with BMI&lt;25 kg/m2 or ≥25 kg/m2 of (both P&lt;0.001), while dulaglutide 0.75mg was superior to glargine for HbA1c reduction from baseline with that difference of -0.29% in patients with BMI&lt;25 kg/m2 (P&lt;0.05), but non-inferior to glargine for HbA1c reduction from baseline with that difference of -0.16% in patients with BMI ≥25 kg/m2.
Conclusions: Irrespective of baseline BMI, Dulaglutide showed effective HbA1c reduction in Chinese T2DM patients compared with glimepiride and glargine. For higher BMI patients treated with oral anti-hyperglycemia medicine, dulaglutide 1.5mg could be a better clinical choice.

Disclosure
Y. Shi: None. B. Zhang: Employee; Self; Eli Lilly and Company. H. Wu: Employee; Self; Eli Lilly and Company.
2315-PUB: A Priori Classification of Type 2 Diabetes Patients to Determine the Needed Therapy Option
Authors: TKACHENKO PAVLO , REITERER FLORIAN , CHRISTENSEN MERETE B. , NØRGAARD KIRSTEN , RE LUIGI DEL 
Published: June 2019

Introduction: T2D patients represent the majority of diabetes patients, and a large and increasing proportion is on insulin, with a huge impact on health care costs. For some a certain degree of automation of insulin dosing and/or regimen adjustment is required. The aim here is to define a priori the automation level required and beneficial for the individual patient.
Methods: Data from an outpatient study of 14 T2D patients currently unsuccessfully using MDI therapy were used as a baseline and different optimized insulin therapy options were tested in simulation. Among them 9 were able to reach their therapeutic goals (defined here as HbA1c &lt; 7% and time in hypoglycemia &lt; 2%) with CSII therapy, while 5 needed an Artificial Pancreas (AP) system. In a next step it was attempted to correlate the simulation outcomes with patient features to check whether it is possible to define the preferred therapy option before implementation by classifying those patients into AP or CSII group based on features that could be available beforehand.
Results: Coefficient of variation (CV) computed from 14 days of CGM data at baseline MDI therapy and HbA1c have been found to be suitable features for an a priori classification via Naïve Bayes or Classification Tree (CT) algorithm which results in a perfect separation of classes.
Conclusion: It was found that it seems possible to predict which subgroup of T2D patients has an additional benefit of using an AP.

Disclosure
P. Tkachenko: None. F. Reiterer: None. M.B. Christensen: None. K. Nørgaard: Advisory Panel; Self; Abbott, Medtronic, Novo Nordisk A/S. Speaker's Bureau; Self; Bayer US, Medtronic, Roche Diabetes Care, Rubin Medical, Sanofi, Zealand Pharma A/S. Stock/Shareholder; Self; Novo Nordisk A/S. L. del Re: None.
2319-PUB: Glycemic Control with XeriSol Regular Insulin and Lispro Insulin: Comparative PK-PD with Humalog and Humulin in STZ Diabetic Rats
Authors: THOHAN SANJEEV , DONOVAN MARTIN J. , HU WENDY T. , CHOI MONICA S. , HESTER DENNIS M. , PRESTRELSKI STEVEN J. 
Published: June 2019

Insulin therapy is the primary treatment option for patients with type 1 and 2 diabetes. Despite considerable advances in insulin chemistry, delivery, and pharmacology, only a small percentage of diabetic patients achieve near normal glycemic levels. Xeris has developed novel room temperature stable insulin formulations that may offer duration of efficacy advantages over commercially available options.
Streptozotocin (65 mg/kg) treated SD rats were given co-formulations of PRAM and Regular Insulin (RI) or Lispro Insulin (LISPRO) as a single injection and compared with dual injection of commercial Symlin, Humulin, or Humalog. Blood samples were evaluated for plasma glucose and PK. A sparse sampling PK scheme resulted in ∼30% CV for glucose values. Mean glucose profiles with reductions in glucose AUC by treatment (efficacy).
XeriSol™ insulins showed comparable efficacy and pharmacokinetic profiles commercial products with up to 4 hours of glycemic control. Xerisol formulations of Insulin and Lispro showed trends for lower sustained means (30-240 min) for glucose levels and slightly longer half-lives than comparative doses of commercial Humulin and Humalog.

Disclosure
S. Thohan: None. M.J. Donovan: None. W.T. Hu: None. M.S. Choi: None. D.M. Hester: None. S.J. Prestrelski: Employee; Self; Xeris Pharmaceuticals, Inc.
2322-PUB: Consistency and Predictability of Control of Glycemic Variability with U200 (Concentrated r-DNA Human Insulin Premix 30/70 - 200 IU/mL) in Type 2 Diabetes Mellitus Patients
Authors: THACKER HEMANT , KESAVADEV JOTHYDEV , INGOLE SHAHU ASHOK , SHAH AGAM , JAIN RISHI 
Published: June 2019

Introduction: In type 2 diabetes mellitus (T2DM) patients, U200 (concentrated r-DNA Human Insulin Premix 30/70 - 200IU/mL) provides good control of glycemic variability with minimal glycemic excursions and substantial time spent in euglycemia. Objective of this subgroup analysis was to assess consistency and predictability of control of glycemic variability with U200 by gender, body mass index (BMI) and daily insulin dose.
Methods: Sixty adult patients with T2DM on treatment with human insulin (regular/NPH/Premix) on stable insulin dose were treated with U200 for 7 days. Variability in 24-hour blood glucose profile measured by CGMS device was compared between various subgroups.
Results: There was no statistically significant difference between male and female, patients with BMI &lt;25 kg/m2 vs. ≥ 25 kg/m2 and with daily insulin dose &lt; 20 IU vs. ≥ 20 IU for mean blood glucose, mean number and duration of hyperglycemic episodes (&gt;150 mg/dL), mean number and duration of hypoglycemic episodes (&lt;70 mg/dL), and % of time spent in euglycemic range (70 - 150 mg/dL).
Conclusion: Mean blood glucose, frequency-duration of excursions and time spent in euglycemic range with U200 were unaffected by gender, BMI and daily insulin dose thereby emphasizing consistency and predictability of control of glycemic variability across a wide range of patients.

Disclosure
H. Thacker: None. J. Kesavadev: None. S.A. Ingole: Employee; Self; Wockhardt. A. Shah: Employee; Self; Wockhardt. R. Jain: Employee; Self; Wockhardt.

Funding
Wockhardt Pharmaceuticals Ltd.
2325-PUB: Estimation Formula for the Long-Term Glycemic Remission in Patients with Newly Diagnosed Type 2 Diabetes Receiving Short-Term Intensive Insulin Therapy
Authors: XU LIJUAN , LIU LIEHUA , WAN XUESI , HUANG ZHIMIN , LI YANBING 
Published: June 2019

Aims: Half of the patients with newly diagnosed type 2 diabetes who received short-term continuous subcutaneous insulin infusion (CSII) were able to achieve a long-term drug-free glycemic remission. It is meaningful to develop an estimation formula to predict the glycemic remission.
Methods: We collected data from three prospective trials conducted from 2002 to 2015. A 2∼3 weeks of CSII was provided for the patients with newly diagnosed diabetes to achieve and maintain normal glucose. The one-year drug-free remission rate was observed. Differences between patients with remission and those without remission were evaluated. Estimation formula was developed by using the logistic regression models. The receiver operating characteristic (ROC) curve was used to determine the sensitivity and specificity of the estimation formula at different score cutoffs.
Results: Data of 244 patients were analyzed. After comparisons, age, gender, body mass index (BMI), high-density lipoprotein cholesterol (HDL-C), red cell distribution width (RDW), ratio of fasting plasma glucose to HbA1c (FPG/HbA1c) at baseline, FPG, postprandial plasma glucose (PPG) and the homeostasis model assessment of insulin resistance (HOMA-IR) after short-term CSII treatment were analyzed. We developed a formula as follows: R=11.936-1.626*HDL-1.56*FPG/HbA1c-0.14*RDW-0.496*FPG’ (FPG’ means FPG after short-term CSII). When R is greater than 0.5, it indicates a possible glycemic remission. The sensitivity, specificity, accuracy, positive predictive value and negative predictive value were 82.8%, 62.2%, 73.7%, 73.3% and 74.2%, respectively.
Conclusions: We provide a prediction formula for long-term glycemic remission. For those who is predicted glycemic non-remission, sequential treatment after CSII secession may be beneficial for the long-term glucose control.

Disclosure
L. Xu: None. L. Liu: None. X. Wan: None. Z. Huang: None. Y. Li: None.
233-OR: Chronic Kidney Disease (CKD) Outcomes with Dulaglutide (DU) vs. Insulin Glargine (IG) in Type 2 Diabetes (T2D) and Moderate-to-Severe CKD by Albuminuria Status: AWARD-7
Authors: TUTTLE KATHERINE R. , RAYNER BRIAN L. , LAKSHMANAN MARK , WOODWARD BRAD , KWAN ANITA , KONIG MANIGE , BOTROS FADY T. 
Published: June 2019

In the AWARD-7 study, conducted in T2D and moderate-to-severe CKD, DU treatment was associated with slower decline in estimated glomerular filtration rate (eGFR) compared to IG. One-year treatment with DU 1.5 mg weekly was associated with a lower rate of CKD outcomes, including eGFR decline ≥40% or end-stage renal disease (ESRD), compared to IG at similar levels of glycemic control and blood pressure. The aim of this post hoc analysis was to determine risk of these CKD outcomes between treatments in albuminuria subgroups. Participants with T2D and CKD stages 3-4 were randomized (1:1:1) to DU 0.75 mg or 1.5 mg weekly versus titrated IG daily, added-on to titrated insulin lispro, for one year. The occurrence of the composite outcome of eGFR decline ≥40% or ESRD was compared between treatments using a Cox proportional hazards model time-to-first event analysis. At baseline, treatment groups had similar eGFR by albuminuria subgroups (Table). The majority of events occurred in patients with macroalbuminuria (Table). Compared to IG, the incidence rate of the composite endpoint was significantly lower for DU 1.5 mg in the overall study population and in those with macroalbuminuria.
In conclusion, the risk of ≥40% eGFR decline or ESRD outcomes was reduced by more than half for DU 1.5 mg compared to IG, particularly in the macroalbuminuric subgroup.

Disclosure
K.R. Tuttle: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Gilead Sciences, Inc., Goldfinch Bio. Research Support; Self; Eli Lilly and Company. B.L. Rayner: Advisory Panel; Self; AstraZeneca, Servier. Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Cipla Medpro, Novartis AG. M. Lakshmanan: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. B. Woodward: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. A. Kwan: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. M. Konig: Employee; Self; Eli Lilly and Company, Eli Lilly and Company. F.T. Botros: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.

Funding
Eli Lilly and Company
2332-PUB: The Effectiveness of Basal Plus Compared with Premixed Insulin in Insulin-Naïve Type 2 Diabetes Patients
Authors: RAGHAVAN ARUN , NANDITHA ARUN , SATHEESH KRISHNAMOORTHY , SNEHALATHA CHAMUKUTTAN , SEELI ABRAHAM CATHERIN , SIMON MARY , SUSAIRAJ PRISCILLA , RAMACHANDRAN AMBADY 
Published: June 2019

Aim: To compare the efficacy and safety of initiating Glargine U100 + Glulisine to Premixed insulin in insulin naïve Asian Indian type 2 diabetes (T2D) patients.
Method: We randomized 101 patients into Glargine U100 + Glulisine (Group 1) and 99 in premixed insulin (Group 2) from 7 different hospitals in Southern India and followed for 24 weeks. Randomized patients were insulin naïve T2D patients on oral antidiabetic drugs.
Results: In both the groups &gt; 80% of patients needed an additional dose of insulin (Glulisine in Group 1 and premixed in group 2). There was a significant reduction in all glycemic levels in both groups (p &lt; 0.05), except for a non-significant reduction in HbA1c in group 2 (Figure 1). The dose at the end of the study was 92 units in Group 1 and 50 units in group 2. There was no clinically significant change in body mass index in both groups. The number of episodes of hypoglycemia was significantly more in premixed insulin BD group compared to Glargine U100 + Glulisine BD group (χ2 - 6.1, p = 0.01).
Conclusion: Marginally better (non-significant) reduction in HbA1c was noted with Glargine U100 + Glulisine compared to premixed insulin. However, the dose required was higher in group 1 than group 2. The overall episodes of symptomatic hypoglycemia were significantly less in Glargine U100 + Glulisine when compared with the premixed insulin. There was no clinically significant change in body weight in both groups.

Disclosure
A. Raghavan: None. A. Nanditha: None. K. Satheesh: None. C. Snehalatha: None. A. Catherin Seeli: None. M. Simon: None. P. Susairaj: None. A. Ramachandran: None.

Funding
Sanofi India Limited