A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo and Once-Weekly Dulaglutide in Participants With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 383
- 试验地点
- 44
- 主要终点
- Change From Baseline in HbA1c in LY3502970 as Compared to Placebo
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of LY3502970 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 30 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 been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin
- •Have a stable body weight for the 3 months prior to randomization
- •Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²)
- •Males must agree to use highly effective methods of contraception
- •Women not of childbearing potential (WNOCBP) may participate in this trial
- •Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.
排除标准
- •Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma
- •Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention
- •Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms
- •Have acute or chronic pancreatitis
- •Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi syndrome)
- •Have gastric emptying abnormality or chronically take medications impacting GI motility
- •Have poorly controlled hypertension
- •Have the following heart conditions within the last 6 months: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure
- •Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD)
- •Have HIV, or Hepatitis B or Hepatitis C
研究组 & 干预措施
3 milligrams (mg) LY3502970
Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).
干预措施: LY3502970 (Drug)
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
干预措施: LY3502970 (Drug)
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
干预措施: LY3502970 (Drug)
36 mg LY3502970 - 1
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
干预措施: LY3502970 (Drug)
36 mg LY3502970 - 2
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
干预措施: LY3502970 (Drug)
45 mg LY3502970 - 1
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
干预措施: LY3502970 (Drug)
45 mg LY3502970 - 2
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
干预措施: LY3502970 (Drug)
1.5 mg Dulaglutide
Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).
干预措施: Dulaglutide (Drug)
Placebo
Participants received matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in HbA1c in LY3502970 as Compared to Placebo
时间窗: Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
次要结局
- Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide(Baseline, Week 26)
- Percentage of Participants With HbA1c ≤ 6.5%(Week 26)
- Percentage of Participants With HbA1c <7.0%(Week 26)
- Change From Baseline in Fasting Serum Glucose(Baseline, Week 26)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970(Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment).)
- Change From Baseline in Body Weight(Baseline, Week 26)