A Phase 3, Randomized, Open Label, Comparator-Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metformin Who Have Not Achieved Target HbA1c
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Beta-cell Function After 52 Weeks of Therapy
研究概览
简要总结
This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using 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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes, but otherwise healthy
- •HbA1c between 6.6% and 9.5%, inclusive.
- •Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.
- •Treated with a stable dose of metformin for at least 2 months prior to screening.
排除标准
- •Patients previously in a study using exenatide.
- •Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).
- •Treated with insulin within 3 months of screening.
研究组 & 干预措施
Exenatide Arm
Exenatide and Metformin
干预措施: exenatide (Drug)
Exenatide Arm
Exenatide and Metformin
干预措施: Metformin (Drug)
Insulin Glargine Arm
Insulin Glargine and Metformin
干预措施: Insulin glargine (Drug)
Insulin Glargine Arm
Insulin Glargine and Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Beta-cell Function After 52 Weeks of Therapy
时间窗: Baseline (week -2) and 52 weeks
Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \[i.e., clamp time 290 min to 300 min\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline \[week -2\]).
次要结局
- Change in Second Phase C-peptide Release(baseline (-2 weeks), 52 weeks, and 56 weeks)
- Beta-cell Function 4 Weeks After Cessation of Therapy(Baseline (week -2) and 56 weeks)
- Change in First Phase C-peptide Release(baseline (week -2), 52 weeks, and 56 weeks)
- Change in Glycosylated Hemoglobin (HbA1c)(Week 0 and week 52)
- Seven Point Self Monitored Blood Glucose (SMBG) Measurements(0 weeks and 52 weeks)
- M-value at Baseline, Week 52 and Week 56(baseline (week -2), 52 weeks, and 56 weeks)
- Change in Fasting Plasma Glucose(0 weeks and 52 weeks)
- Change in Body Weight(0 weeks and 52 weeks)