The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 737
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c at 26 Weeks
研究概览
简要总结
The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to glimepiride in participants with type 2 diabetes mellitus who have inadequate glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.
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
- Triple (Participant, Care Provider, 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
- •Type 2 diabetes mellitus
- •OAM-naïve or have been taking OAM monotherapy for at least 3 months
- •Glycosylated Hemoglobin (HbA1c) value of ≥7.0% to ≤10.5% for OAM-naïve participants or ≥6.5% to ≤10.0% for participants taking OAM monotherapy
- •Adult men or adult non-pregnant, non-breastfeeding women
- •Stable weight (±5%) ≥3 months prior to screening
- •Body mass index (BMI) of ≥19.0 to ≤35.0 kilograms per square meter (kg/m^2)
排除标准
- •Have type 1 diabetes mellitus
- •Have previously been treated with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic during the 3 months before screening
- •Are currently taking dipeptidylpeptidase-IV (DPP-IV) inhibitor and thiazolidinediones (TZD) during the 3 months before screening
- •Have gastric emptying abnormality
- •Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke
- •Have poorly controlled hypertension (systolic blood pressure above 160 millimeters of mercury [mmHg] or diastolic blood pressure above 95 mmHg)
- •Have impaired liver function
- •Have impaired kidney function
- •Have history of chronic pancreatitis or acute pancreatitis
- •Have a serum calcitonin ≥20 picogram/milliliter (pg/mL)
- •Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma or multiple endocrine neoplasia type 2 (MEN 2)
研究组 & 干预措施
1.5 mg Dulaglutide
1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
干预措施: Dulaglutide (Drug)
1.5 mg Dulaglutide
1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
干预措施: Placebo as Capsules (Drug)
0.75 mg Dulaglutide
0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
干预措施: Dulaglutide (Drug)
0.75 mg Dulaglutide
0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
干预措施: Placebo as Capsules (Drug)
Glimepiride
1 to 3 mg per day (mg/day) glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
干预措施: Glimepiride (Drug)
Glimepiride
1 to 3 mg per day (mg/day) glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
干预措施: Placebo as SC Injection (Drug)
结局指标
主要结局
Change From Baseline in HbA1c at 26 Weeks
时间窗: Baseline, 26 Weeks
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline HbA1c as covariate; and participant as a random effect.
次要结局
- Change From Baseline in Serum Calcitonin at 26 Weeks(Baseline, 26 Weeks)
- Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks(Baseline, 26 Weeks)
- Change From Baseline in Sitting Blood Pressure at 26 Weeks(Baseline, 26 Weeks)
- Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia Corrected QT (QTcF) Interval and P-R Wave (PR) Interval at 26 Weeks(Baseline, 26 Weeks)
- Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks(26 Weeks)
- Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks(Baseline, 26 Weeks)
- Change From Baseline in Heart Rate From ECG at 26 Weeks(Baseline, 26 Weeks)
- Change From Baseline in Body Weight at 26 Weeks(Baseline, 26 Weeks)
- Change From Baseline in Body Mass Index (BMI) at 26 Weeks(Baseline, 26 Weeks)
- Rate of Hypoglycemic Episodes(Baseline through 26 Weeks)
- Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks(Baseline, up to 26 Weeks)
- Change From Baseline in Pancreatic Enzymes at 26 Weeks(Baseline, 26 Weeks)
- Visual Analog Scale (VAS) Score at 26 Weeks(Week 26)
- Number of Participants With Self-Reported Hypoglycemic Episodes(Baseline through 26 Weeks)
- Percentage of Participants Developing Antibodies to Dulaglutide(Baseline through 26 Weeks)
- Number of Participants With Adjudicated Cardiovascular Events(Baseline through 26 Weeks)
- Number of Participants With Adjudicated Pancreatitis(Baseline through 26 Weeks)
- Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks(Baseline, up to 26 Weeks)
- Change From Baseline in Sitting Pulse Rate at 26 Weeks(Baseline, 26 Weeks)
- European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks(Week 26)