A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian 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
- 1,179
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
研究概览
简要总结
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and females, 18 years old, with type 2 diabetes and with inadequate glycemic control
- •Drug naive or treated with anti-diabetic medication for < 24 weeks
- •C-peptide ≥ 1.0 ng/mL
- •Body Mass Index ≤ 45.0 kg/m²
排除标准
- •AST and/or ALT > 3 times ULN
- •Serum total bilirubin > 2 mg/dL
- •Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
- •Creatine kinase ≥ 3 times ULN
- •Symptoms of severely uncontrolled diabetes
- •Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
研究组 & 干预措施
Group 1
干预措施: Dapagliflozin (Drug)
Group 1
干预措施: Metformin (Drug)
Group 1
干预措施: Dapagliflozin Placebo (Drug)
Group 2
干预措施: Dapagliflozin (Drug)
Group 2
干预措施: Metformin (Drug)
Group 2
干预措施: Dapagliflozin Placebo (Drug)
Group 3
干预措施: Metformin (Drug)
Group 3
干预措施: Dapagliflozin Placebo (Drug)
结局指标
主要结局
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
时间窗: From Baseline to Week 24
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
次要结局
- Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)
- Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)
- Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)
- Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)