A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 565
- 试验地点
- 80
- 主要终点
- Change From Baseline in Hemoglobin A1c (A1C) at Week 24
研究概览
简要总结
The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone
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 in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (defined as rescue medication) 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 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.
- •Hemoglobin A1c (HbA1c) > = 7.0% and < = 10.5%
- •Body mass index < = 45kg/m2
- •Fasting C-peptide > = 1 ng/mL
排除标准
- •Symptomatic poorly controlled diabetes
- •Recent cardiac or cerebrovascular event
- •Serum creatinine > = 2.0 mg/dL
研究组 & 干预措施
Saxagliptin plus open-label TZD (A)
Saxagliptin PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: Saxagliptin (Drug)
Saxagliptin plus open-label TZD (A)
Saxagliptin PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: pioglitazone (Drug)
Saxagliptin plus open-label TZD (A)
Saxagliptin PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: rosiglitazone (Drug)
Saxagliptin plus open-label TZD (A)
Saxagliptin PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: metformin (Drug)
Saxagliptin plus open-label TZD (B)
Saxagliptin PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: Saxagliptin (Drug)
Saxagliptin plus open-label TZD (B)
Saxagliptin PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: pioglitazone (Drug)
Saxagliptin plus open-label TZD (B)
Saxagliptin PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: rosiglitazone (Drug)
Saxagliptin plus open-label TZD (B)
Saxagliptin PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: metformin (Drug)
Placebo plus open-label TZD (C)
Placebo PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: Placebo (Drug)
Placebo plus open-label TZD (C)
Placebo PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: pioglitazone (Drug)
Placebo plus open-label TZD (C)
Placebo PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: rosiglitazone (Drug)
Placebo plus open-label TZD (C)
Placebo PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
干预措施: metformin (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
时间窗: Baseline, Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24(Baseline, Week 24)
- Percentage of Participants Achieving A1c <7% at Week 24(Week 24)
- Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24(Baseline, Week 24)