NCT03495102已完成3 期
A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,842
- 试验地点
- 206
- 主要终点
- Change in Hemoglobin A1c (HbA1c) From Baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.
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 type 2 diabetes mellitus (T2DM) for at least 6 months
- •Have been treated with stable metformin dose for at least 3 months
- •Have HbA1c ≥7.5% and ≤11.0% at study entry
- •Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m^2)
排除标准
- •Have type 1 diabetes mellitus
- •Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (≤14 days)
- •Have been taking any other medicine for diabetes (other than metformin) during the last 3 months
- •Have used in the last 3 months (or plan to use) prescription weight loss medications
- •Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss
- •Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes)
- •Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (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
- •Had chronic or acute pancreatitis any time prior to study entry
- •Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity
- •Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73m^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in
- •Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
- •Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
研究组 & 干预措施
Dulaglutide 1.5 mg
Active Comparator
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
干预措施: Dulaglutide (Drug)
Dulaglutide 3 mg
Experimental
Dulaglutide 3 mg administered SC once a week.
干预措施: Dulaglutide (Drug)
Dulaglutide 4.5 mg
Experimental
Dulaglutide 4.5 mg administered SC once a week.
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c) From Baseline
时间窗: Baseline, Week 36
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
次要结局
- Percentage of Participants Achieving HbA1c Target <7.0%(Week 36)
- Rate of Documented Symptomatic Hypoglycemic Episodes(Week 36)
- Change in Fasting Serum Glucose (FSG) From Baseline(Baseline, Week 36)
- Change in Body Weight From Baseline(Baseline, Week 36)
- Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)(Week 4, Week 12, Week 36, Week 52)
- Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State(Week 4, Week 12, Week 36, Week 52)
研究者
研究点 (206)
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