NCT02973100已完成2 期
A Phase 2, Double-Blind, Placebo-Controlled, 18-Week Trial of Investigational Dulaglutide Doses Versus Placebo in Patients With Type 2 Diabetes on Metformin Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 318
- 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 purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification
- •Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory
- •Have been treated with stable doses of metformin for at least 3 months
- •Have a body mass index (BMI) ≥25 kilograms per square meter
排除标准
- •Have type 1 diabetes (T1D)
- •Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past
- •Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke)
- •Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
- •Have had chronic or acute pancreatitis any time prior to study entry
- •Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation
- •Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry
研究组 & 干预措施
Dulaglutide 4.5mg
Experimental
4.5mg of Dulaglutide administered subcutaneously (SC)
干预措施: Dulaglutide (Drug)
Dulaglutide 3.0mg
Experimental
3.0mg of Dulaglutide administered SC
干预措施: Dulaglutide (Drug)
Dulaglutide 1.5mg
Active Comparator
1.5mg of Dulaglutide administered SC
干预措施: Dulaglutide (Drug)
Placebo
Placebo Comparator
Placebo administered SC
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, Week 18
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 as a covariate, pooled country, treatment, time, treatment\*time as fixed effects.
次要结局
- Percentage of Participants Discontinuing Study Drug Due to Adverse Events(Baseline through Week 18)
- Change From Baseline in Fasting Serum Glucose (FSG)(Baseline, Week 18)
- Change From Baseline in Body Weight(Baseline, Week 18)
- Rate of Documented Symptomatic Hypoglycemia(Week 18)
- Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide(0, 2, 4, 6, 10, 18, 22 weeks and early termination)
- Percentage of Participants With HbA1c of <7.0%(Week 18)
- Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide(0, 2, 4, 6, 10, 18, 22 weeks and early termination)
研究者
研究点 (40)
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