A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Bexagliflozin Versus Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 426
- 试验地点
- 3
- 主要终点
- Change From Baseline in HbA1c at Week 60
研究概览
简要总结
The purpose of this study is to investigate the effect of bexagliflozin compared to glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).
详细描述
Approximately 420 subjects with inadequately controlled T2DM on metformin will be recruited from North America and Europe. Subjects will be randomly assigned to receive bexagliflozin tablets, 20 mg, or glimepiride capsules, 2, 4 or 6 mg, in a ratio of 1:1 once daily for 96 weeks. Subjects will continue to take metformin for the duration of the study.
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
- •Diagnosis of T2DM
- •Currently taking metformin or taking metformin and one additional oral medication for diabetes
- •Body Mass Index (BMI) ≤ 45 kg/m2
- •Stable dose of blood pressure or cholesterol medications (if applicable) for at least 30 days
排除标准
- •Hypersensitivity or other contraindication to the safe use of sulfonylurea or glimepiride
- •Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
- •Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs
- •History of genitourinary tract infections
- •Evidence of abnormal liver function
- •Myocardial infarction, stroke or hospitalization for heart failure within 3 months of screening
- •Prior kidney transplant or evidence of kidney problems
- •Pregnant or nursing
研究组 & 干预措施
Bexagliflozin
Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for glimepiride daily for the duration of the study.
干预措施: Bexagliflozin (Drug)
Bexagliflozin
Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for glimepiride daily for the duration of the study.
干预措施: Placebo for Glimepiride (Drug)
Glimepiride
Subjects will receive a glimepiride capsule, 2, 4 or 6 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.
干预措施: Placebo for Bexagliflozin (Drug)
Glimepiride
Subjects will receive a glimepiride capsule, 2, 4 or 6 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.
干预措施: Glimepiride (Drug)
结局指标
主要结局
Change From Baseline in HbA1c at Week 60
时间窗: Baseline and Week 60
The primary objective is to demonstrate that bexagliflozin is non-inferior to glimepiride by evaluating the treatment effect on HbA1c reduction at week 60 in subjects whose T2DM is inadequately controlled by metformin. The least square mean (LSM) change from baseline to Week 60 was analyzed using a mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA).
次要结局
- Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks(During the 96 week treatment period)
- Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2(Baseline and 60 weeks)
- Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg(Baseline and 60 weeks)
- Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60.(Baseline to Week 60)