Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 34
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
研究概览
简要总结
The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.
详细描述
The study will include a 12 week blinded treatment period, where neither the participant nor the investigator will know to which treatment each individual is assigned. Thereafter follows a 12 week period where participants and the investigator will know which treatment they are assigned to. Participants' on LY2944876 and on exenatide extended-release continue treatment in this period, those who received placebo will be followed without treatment.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women with diabetes mellitus Type 2
- •Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening
- •Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening
排除标准
- •Women of child bearing potential
- •Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months
- •Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year
- •Participants with impaired renal function (serum creatinine >124 micromole per liter (µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in men)
研究组 & 干预措施
10 mg LY2944876
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: LY2944876 (Drug)
10 mg LY2944876
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: Metformin (Drug)
15 mg LY2944876
15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: LY2944876 (Drug)
15 mg LY2944876
15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: Metformin (Drug)
30 mg LY2944876
30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: LY2944876 (Drug)
30 mg LY2944876
30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: Metformin (Drug)
50 mg LY2944876
50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: LY2944876 (Drug)
50 mg LY2944876
50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: Metformin (Drug)
Exenatide extended-release
2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: Exenatide extended-release (Drug)
Exenatide extended-release
2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: Metformin (Drug)
Placebo
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: Placebo (Drug)
Placebo
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
干预措施: Metformin (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
时间窗: Baseline, Week 12
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
次要结局
- Change From Baseline in HbA1c at Week 24(Baseline, Week 24)
- Percent Change From Baseline in Body Weight(Baseline, Week 12; Baseline, Week 24)
- Change From Baseline in Fasting Blood Glucose(Baseline, Week 12; Baseline, Week 24)
- Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values(Baseline, Week (Wk) 12; Baseline, Week 24)
- Change From Baseline in Lipids(Baseline, Week 24)
- Change From Baseline in Fasting Fibroblast Growth Factor 21(Baseline, Week 12; Baseline, Week 24)
- Percentage of Participants Requiring Rescue Therapy(Baseline through Therapy Completion (Week 24))
- Percentage of Participants Developing Anti-Drug Antibodies to LY2944876(Week 12 and Week 24)
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876(Baseline, Week 8, Week 12, Week 16, Week 20, Week 24)
- Change From Baseline in Adiponectin Levels(Baseline, Week 12; Baseline, Week 24)
- Change From Baseline in Beta-Hydroxy Butyrate Levels(Baseline, Week 12; Baseline, Week 24)
- Change From Baseline in Glucagon Levels(Baseline, Week 12; Baseline, Week 24)
- Change From Baseline in Insulin Levels(Baseline, Week 12; Baseline, Week 24)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876(Baseline, Week 8, Week 12, Week 16, Week 20, Week 24)