The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 774
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (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 once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.
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
- None
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 for at least 6 months
- •Have been taking metformin and/or a sulfonylurea for at least 3 months before screening and have been on a stable therapeutic dose for at least 8 weeks
- •Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤11.0%
- •Adult men or adult non-pregnant, non-breastfeeding women
- •Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m^2)
- •Stable weight (±5%) ≥3 months prior to screening
排除标准
- •Have type 1 diabetes mellitus
- •Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic
- •Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase inhibitor (AGI), thiazolidinedione (TZD), or glinide
- •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 millimeter 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 picograms per 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 added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.
干预措施: Dulaglutide (Drug)
1.5 mg Dulaglutide
1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.
干预措施: Metformin (Drug)
1.5 mg Dulaglutide
1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.
干预措施: Sulfonylureas (Drug)
0.75 mg Dulaglutide
0.75 mg Dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.
干预措施: Dulaglutide (Drug)
0.75 mg Dulaglutide
0.75 mg Dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.
干预措施: Metformin (Drug)
0.75 mg Dulaglutide
0.75 mg Dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.
干预措施: Sulfonylureas (Drug)
Insulin Glargine
Insulin glargine administered based on fasting blood glucose concentrations per the dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea for up to 52 weeks.
干预措施: Insulin glargine (Drug)
Insulin Glargine
Insulin glargine administered based on fasting blood glucose concentrations per the dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea for up to 52 weeks.
干预措施: Metformin (Drug)
Insulin Glargine
Insulin glargine administered based on fasting blood glucose concentrations per the dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea for up to 52 weeks.
干预措施: Sulfonylureas (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (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 square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.
次要结局
- Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks(Baseline, 26 Weeks, 52 Weeks)
- Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks(Baseline, 26 Weeks, 52 Weeks)
- Rate of Hypoglycemic Events(Baseline through 26 weeks and 52 weeks)
- Number of Self-reported Hypoglycemic Events(Baseline through 26 Weeks and 52 Weeks)
- Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)(Baseline, 26 Weeks, 52 Weeks)
- Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate(Baseline, 26 Weeks, 52 Weeks)
- Change From Baseline in Serum Calcitonin(Baseline, 26 Weeks, 52 Weeks)
- Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval(Baseline, 26 Weeks, 52 Weeks)
- Change in Body Mass Index(Baseline, 26 Weeks, 52 Weeks)
- Number of Participants With Adjudicated Cardiovascular (CV) Events(Baseline through 52 weeks)
- Number of Participants With Adjudicated Pancreatitis(Baseline through 52 Weeks)
- Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)(Baseline, 26 Weeks, 52 Weeks)
- Change From Baseline in HbA1c at 52 Weeks(Baseline, 52 Weeks)
- Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks(Up to 26 and 52 weeks)
- Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks(Baseline, 26 Weeks, 52 Weeks)
- Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks(Baseline, 26 weeks, 52 weeks)
- Change From Baseline in Body Weight(Baseline, 26 Weeks, 52 Weeks)
- Change From Baseline in Pancreatic Enzymes(Baseline, 26 Weeks, 52 Weeks)
- Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)(Baseline through 52 Weeks)
- Change From Baseline in EQ-5D Visual Analog Scale Score(Baseline, 26 weeks, 52 weeks)
- EQ-5D Health State Score Responses(Baseline, 26 Weeks, 52 Weeks)