A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy 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
- 497
- 试验地点
- 27
- 主要终点
- Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
研究概览
简要总结
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone. 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
- 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
- •Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
- •Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
- •C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
- •Body Mass Index ≤ 45 kg/m²
- •Must be able to perform self monitoring of blood glucose
排除标准
- •aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3* upper limit of normal (ULN)
- •Serum Total bilirubin >2 mg/dL (34.2 µmol/L)
- •Creatinine kinase >3* ULN
- •Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
- •Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
研究组 & 干预措施
Dapagliflozin 1 mg
Dapagliflozin: 1 mg
干预措施: Dapagliflozin (Drug)
Dapagliflozin 2.5 mg
Dapagliflozin: 2.5 mg
干预措施: Dapagliflozin (Drug)
Dapagliflozin 5 mg
Dapagliflozin: 5 mg
干预措施: Dapagliflozin (Drug)
Placebo
Placebo: 0 mg
干预措施: 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) - All Randomized Participants
时间窗: Baseline (Day 1), Week 24
Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) 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 values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
次要结局
- Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants(Baseline (Day 1), Week 24)
- Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants(Day 1 of Double Blind Period to end of Week 24 Plus 30 days)
- Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants(Baseline (Day 1), Week 24)
- Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants(Week 24)
- Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants(Baseline to Week 24/end of treatment plus 4 days)
- Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants(Baseline (Day 1), Week 24)
- Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants(Baseline to last dose plus 4 days in 12 Week Double Blind Period)
- Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants(Baseline (Day 1), Week 24)
- Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants(Baseline (Day 1), Week 24)
- Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants(Baseline (Day 1), Week 24)
- Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants(Baseline (Day 1), Week 24)