A Phase 2b, Multi-center, Double-blind, Placebo-controlled, Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets on HbA1c in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 50
- 主要终点
- Change in HbA1c After 12 Weeks of Treatment
研究概览
简要总结
The purpose of this study was to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as a Sodium Glucose co-Transporter 2 (SGLT2) Inhibitor. This study was to enroll both treatment naive and those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320 subjects eligible for randomization was to receive bexagliflozin tablets, 5, 10, 20 mg or placebo, once daily for 12 weeks in an outpatient setting.
详细描述
The study was a phase 2b multicenter, double-blind, placebo-controlled parallel group study to assess the effect of once daily bexagliflozin tablets on HbA1c in either treatment-naïve T2DM subjects or in subjects who were treated with one oral anti-diabetic agent. Treatment naïve subjects were eligible if their HbA1c values were between 7% and 8.5% at the screening visit while subjects who were treated with one oral hypoglycemic agent (OHA) were eligible if their HbA1c value was between 6.5% and 8.5% at screening and underwent a 6 or 10 week washout period. In addition, all eligible subjects underwent a two week placebo run-in period and those who showed good compliance in taking study medication (i.e., missed no more than one dose during the run-in period) during this period and whose HbA1c values were between 7 and 8.5% at the end of the run-in period were eligible for randomization.
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
- 20 Years 至 —（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
研究组 & 干预措施
Bexagliflozin tablets, 5 mg
Bexagliflozin tablets, 5 mg, once daily by mouth before breakfast
干预措施: Bexagliflozin tablets (Drug)
Bexagliflozin tablets, 10 mg
Bexagliflozin tablets, 10 mg, once daily by mouth before breakfast
干预措施: Bexagliflozin tablets (Drug)
Bexagliflozin tablets, 20 mg
Bexagliflozin tablets, 20 mg, once daily by mouth before breakfast
干预措施: Bexagliflozin tablets (Drug)
Bexagliflozin tablets, placebo
Bexagliflozin tablets, placebo, once daily by mouth before breakfast
干预措施: Bexagliflozin tablets, placebo (Drug)
结局指标
主要结局
Change in HbA1c After 12 Weeks of Treatment
时间窗: 12 weeks
Mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA) with baseline HbA1c as a covariate will be fit to the available data, incorporating all visits at which HbA1c was measured for each subject including scheduled visits at Weeks 2, 6, and 12 as well as unscheduled visits for measurements of HbA1c. Treatment (placebo, 5 mg, 10 mg, 20 mg), study center, prior anti-diabetic treatment status, study visit and treatment-by-visit interaction will be applied as fixed effects and subject as a random effect. The least square mean (LSM) change from baseline to Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes.
次要结局
- Change in Body Weight Over Time(Baseline to Week 2, Week 6 and Week 12)
- Change in Systolic and Diastolic Blood Pressure Over Time(Baseline to Week 2, Week 6 and Week 12)
- Change in HbA1c Over Time(Baseline to Week 2, Week 6 and Week 12)
- Proportion of Subjects With HbA1c < 7%(Baseline to up to 12 weeks)
- Change in Fasting Plasma Glucose (FPG) Over Time(Baseline to Week 2, Week 6 and Week 12)