A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 40
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have Type 2 Diabetes (T2D)
- •Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or with a stable dose of metformin (either immediate release or extended release, 1000 milligram (mg)/day and not more than the locally approved dose) for at least 3 months prior to screening.
排除标准
- •Have type 1 diabetes mellitus (T1DM)
- •Have ketoacidosis
- •Have retinopathy, maculopathy
- •Have history of pancreatitis
- •Have obesity induced by other endocrine disorders
- •Have uncontrolled hypertension
- •Have acute or chronic hepatitis
- •Have chronic kidney disease
- •Have an autoimmune abnormality for example, lupus or rheumatoid arthritis
- •Have an active or untreated malignancy
研究组 & 干预措施
0.5 milligrams (mg) LY3437943
Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).
干预措施: LY3437943 (Drug)
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
干预措施: LY3437943 (Drug)
4 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 administered as SC injection QW.
干预措施: LY3437943 (Drug)
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
干预措施: LY3437943 (Drug)
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.
干预措施: LY3437943 (Drug)
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as a SC injection QW.
干预措施: LY3437943 (Drug)
1.5 mg Dulaglutide
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
干预措施: Dulaglutide (Drug)
Placebo
Participants received placebo administered as SC injection QW.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline, 24 Weeks
Change in HbA1c (%) from baseline in LY3437943 relative to placebo. HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
次要结局
- Change From Baseline in Body Weight(Baseline, 36 Weeks)
- Percentage of Participant Reaching HbA1c <7.0%(Week 36)
- Change From Baseline in Fasting Blood Glucose (FBG)(Baseline, 36 Weeks)
- Change From Baseline in HbA1c(Baseline, 36 Weeks)
- Percentage of Participants Reaching HbA1c <7.0%(Week 24)
- Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943(Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36)