NCT01624259已完成3 期
A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)
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
- 599
- 试验地点
- 1
- 主要终点
- Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
研究概览
简要总结
The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.
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
- •Type 2 diabetes
- •Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit
- •Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal to 10.0%
- •Accept continued treatment with metformin throughout the trial, as required per protocol
- •Men and nonpregnant women aged greater than or equal to 18 years
- •Stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening
- •Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m^2)
排除标准
- •Have type 1 diabetes mellitus
- •Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within the 3 months prior to the first study visit
- •Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin use within 3 months prior to the first study visit
- •Have been treated with drugs that promote weight loss within 3 months of the first study visit
- •Are receiving chronic (greater than 14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit
- •Have had any of the following cardiovascular conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident
- •Have a known clinically significant gastric emptying abnormality (such as, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery
- •Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level greater than or equal to 3 times the upper limit of normal
- •Have a history of chronic pancreatitis or acute idiopathic pancreatitis or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit
- •Have a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dL) (male) or greater than or equal to 1.4 mg/dL (female), or a creatinine clearance less than 60 milliliters/minute (mL/minute)
- •Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B, respectively) in the absence of known C-cell hyperplasia (this exclusion includes those participants with a family history of MEN 2A or 2B whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation)
- •Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
- •Have a serum calcitonin greater than or equal to 20 picograms/milliliter (pg/mL)
研究组 & 干预措施
1.5 mg LY2189265
Experimental
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks
干预措施: LY2189265 (Drug)
1.5 mg LY2189265
Experimental
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks
干预措施: Metformin (Drug)
Liraglutide
Active Comparator
Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.2 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks
干预措施: Liraglutide (Drug)
Liraglutide
Active Comparator
Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.2 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.8 mg, SC, once daily for 24 weeks
Metformin: at least 1500 mg/day, oral, for 26 weeks
干预措施: Metformin (Drug)
结局指标
主要结局
Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
时间窗: Baseline, 26 Weeks
Least Squares (LS) means of the glycosylated hemoglobin A1c (HbA1c) change from baseline to the primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect, and baseline HbA1c as covariates, via a mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).
次要结局
- Change From Baseline in Body Weight at 26 Weeks(Baseline, Up to 26 Weeks)
- Change From Baseline in Body Mass Index (BMI) at 26 Weeks(Baseline, Up to 26 Weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks(Baseline, Up to 26 Weeks)
- Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks(Baseline, 26 Weeks)
- Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks(Up to 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 Heart Rate (HR) at 26 Weeks(Baseline, 26 Weeks)
- Number of Participants With Reported and Adjudicated Cardiovascular Events(Baseline up to 26 Weeks)
- Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks(Baseline, Up to 26 Weeks)
- Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks(Baseline, 26 Weeks)
- Change From Baseline in Blood Pressure (BP) at 26 Weeks(Baseline, 26 Weeks)
- Number of Participants With Adjudicated Acute Pancreatitis Events(Baseline up to 30 Weeks)
- Change From Baseline in Calcitonin at 26 Weeks(Baseline, Up to 26 Weeks)
- Change From Baseline in Lipase at 26 Weeks(Baseline, Up to 26 Weeks)
- Change From Baseline in Amylase at 26 Weeks(Baseline, Up to 26 Weeks)
- Percentage of Participants With Self-Reported Hypoglycemia Events(Baseline through 26 Weeks)
- Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia(Baseline through 26 Weeks)
- Rate of Hypoglycemic Events Adjusted Per 30 Days(Baseline through 26 Weeks)
- Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia(Baseline through 26 Weeks)
- Number of Participants With Allergic or Hypersensitivity Reactions(Baseline through 26 Weeks)
- Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose(Baseline up to 4 Weeks Post Last Dose of Study Drug)
- Percent Change From Baseline in Lipid Parameters at 26 Weeks(Baseline, Up to 26 Weeks)
研究者
研究点 (1)
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