A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 365
- 试验地点
- 51
- 主要终点
- Change From Baseline in Hemoglobin A1 (A1C) at Week 24
研究概览
简要总结
The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise
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 (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 diabetes
- •Inadequate blood sugar control
排除标准
- •Previous treatment for diabetes
- •Current treatment with other medications to lower blood sugar
- •Major heart, liver or kidney problems
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
Saxagliptin 2.5 mg QAM (A)
PLUS open-label metformin (as needed as rescue medication)
干预措施: Saxagliptin (Drug)
Saxagliptin 2.5 mg QAM (A)
PLUS open-label metformin (as needed as rescue medication)
干预措施: metformin (Drug)
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
PLUS open-label metformin (as needed as rescue medication)
干预措施: Saxagliptin (Drug)
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
PLUS open-label metformin (as needed as rescue medication)
干预措施: metformin (Drug)
Saxagliptin 5 mg QAM (C)
PLUS open-label metformin (as needed as rescue medication)
干预措施: Saxagliptin (Drug)
Saxagliptin 5 mg QAM (C)
PLUS open-label metformin (as needed as rescue medication)
干预措施: metformin (Drug)
Saxagliptin 5 mg QPM (D)
PLUS open-label metformin (as needed as rescue medication)
干预措施: Saxagliptin (Drug)
Saxagliptin 5 mg QPM (D)
PLUS open-label metformin (as needed as rescue medication)
干预措施: metformin (Drug)
Placebo (E)
PLUS open-label metformin (as needed as rescue medication)
干预措施: Placebo (Drug)
Placebo (E)
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 A1 (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
- 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)
- Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM(Baseline, Week 24)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24(Baseline, Week 24)