A 16 Week Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of a New Medication (GSK523338) to Lower LDL-c and HbA1c in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 369
- 试验地点
- 86
- 主要终点
- Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy
研究概览
简要总结
This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations. All study related medicines and medical examinations will be provided at no cost to the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy
时间窗: Baseline (Week 0) and Week 6
Median percent change from Baseline to Week 6 in LDL-c in FDC and RSG monotherapy was reported. Percent change from Baseline = 100\*(exponent \[change on log scale\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of an analysis of covariance (ANCOVA) with terms for treatment, gender, current sulfonylurea use (at baseline), country, and Baseline measurement. ANCOVA for LDL-c were performed based on log-transformed data.
次要结局
- Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)(Baseline (Week 0) and Week 16)
- On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate(Up to Week 16)
- Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6(Week 6)
- Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16(Up to Week 16)
- Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16(Week 16)
- Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy(Baseline (Week 0) and Week 16)
- Median Percent Change From Baseline to Week 6 in LDL-c(Baseline (Week 0) and Week 6)
- Mean Change From Baseline to Week 16 in HbA1c(Baseline (Week 0) and Week 16)
- On-Therapy Change From Baseline in Body Weight(Up to Week 16)
- Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine(Up to Week 16)
- Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline(Up to Week 16)
- Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)(Up to Week 16)