Mechanism of Action and Efficacy of Saxagliptin (BMS-477118) in the Treatment of Type 2 Diabetic Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 156
- 试验地点
- 3
- 主要终点
- Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12
研究概览
简要总结
The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes
详细描述
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Drug naive
- •Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
- •Fasting C-peptide ≥1.0 ng/mL
- •Body mass index ≤40 kg/m²
排除标准
- •Recent cardiac or cerebrovascular event
- •Elevated serum creatinine
研究组 & 干预措施
Saxagliptin (A)
Metformin 500-1500 mg (open-label, as needed for rescue in LT)
干预措施: Saxagliptin (Drug)
Placebo (ST) / Metformin (LT) (B)
Metformin 500-1500 mg (open-label, as needed for rescue in LT)
干预措施: Placebo (Drug)
Placebo (ST) / Metformin (LT) (B)
Metformin 500-1500 mg (open-label, as needed for rescue in LT)
干预措施: Metformin (blinded) (Drug)
Placebo (ST) / Metformin (LT) (B)
Metformin 500-1500 mg (open-label, as needed for rescue in LT)
干预措施: Metformin (open-label) (Drug)
结局指标
主要结局
Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12
时间窗: Baseline, Week 12
Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load \[intravenous-oral hyperglycemic clamp (180-480 minutes)\] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.
次要结局
- Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12(Baseline, Week 12)