A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Obese Adults With Type-2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 31
- 主要终点
- Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults with type-2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type-2 diabetes mellitus with HbA1c ≥6.5% to less than 10.0%
- •Body mass index 30.0 to 50.0
排除标准
- •Any significant acute or chronic medical illness
- •Inability to self-administer subcutaneous injections
- •Inability to be venipunctured
- •Evidence of organ dysfunction beyond what is consistent with the target population
- •History of allergy to PEGylated compounds or Fibroblast growth factor 21 (FGF21) related compounds
研究组 & 干预措施
Treatment C: BMS-986036 (5 mg Daily)
BMS-986036 5 mg subcutaneous injection once daily for 12 weeks
干预措施: BMS-986036 (Biological)
Arm 2: Treatment B: BMS-986036 (1 mg Daily)
BMS-986036 1 mg subcutaneous injection once daily for 12 weeks
干预措施: BMS-986036 (Biological)
Treatment D: BMS-986036 (20 mg Daily)
BMS-986036 20 mg subcutaneous injection once daily for 12 weeks
干预措施: BMS-986036 (Biological)
Treatment E: BMS-986036 (20 mg Weekly)
BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks
Followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks
干预措施: BMS-986036 (Biological)
Treatment A: Placebo (Matching with BMS-986036 - Daily)
Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks
干预措施: Placebo (Matching with BMS-986036) (Biological)
Treatment E: BMS-986036 (20 mg Weekly)
BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks
Followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks
干预措施: Placebo (Matching with BMS-986036) (Biological)
结局指标
主要结局
Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12
时间窗: Baseline (Day 1) and Week 12
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Percent Change in Glycosylated Hemoglobin A1c (HbA1c) from Baseline to Week 12 was reported.
次要结局
- Change in Body Weight From Baseline to Week 12(Baseline (Day 1) and Week 12)
- Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)(Baseline (Day 1) and Week 12)
- Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Baseline (Day 1) and Week 12)
- Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI)(Baseline (Day 1) and Week 12)
- Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12(Baseline (Day 1) and Week 12)
- Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12(Bseline (Day 1) and Week 12)
- Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12(Baseline (Day 1) and Week 12)
- Average Concentration (Cavg) of C-terminal Intact BMS-986036(Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126))
- Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036(Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126))
- Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) of C-terminal Intact BMS-986036(Pre-dose, 6, 24 hours postdose on Week 8)
- Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of C-terminal Intact BMS-986036(Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126))
- Average Concentration (Cavg) of Total BMS-986036(Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126))
- Maximum Observed Concentration (Cmax) of Total BMS-986036(Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126))
- Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036(Pre-dose, 6, 24 hours postdose on Week 8)
- Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036(Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126))
- Percentage of Participants With ANTI-BMS-986036 Antibody Response(Baseline and Day 126)