NCT02537470已完成2 期
A 12-week Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Determine the Efficacy and Safety of Biphasic Remogliflozin Etabonate When Administered to Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- BHV Pharma
- 入组人数
- 191
- 试验地点
- 19
- 主要终点
- Glycosylated haemoglobin A1c (HbA1c) at Week 12
研究概览
简要总结
This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered over 12 weeks in subjects with type 2 diabetes mellitus.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent
- •Subject with clinical diagnosis of type 2 diabetes
- •HbA1c 7.0 - 10.5% inclusive at Visit 1.
排除标准
- •History of metabolic acidosis or ketoacidosis.
- •Current active renal disease that is not related to hypertension or type 2 diabetes (e.g. non-diabetic glomerulonephritis, interstitial nephritis, symptomatic nephrolithiasis, etc.)
- •Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.
研究组 & 干预措施
Arm 1
Other
Placebo
干预措施: Placebo (Other)
Arm 2
Experimental
Biphasic remogliflozin etabonate
干预措施: Biphasic Remogliflozin Etabonate (Drug)
结局指标
主要结局
Glycosylated haemoglobin A1c (HbA1c) at Week 12
时间窗: 12 weeks
次要结局
- HbA1c(at weeks 4, 8 and 12)
- Fasting plasma glucose (FPG)(at Weeks 4, 8 and 12)
- Insulin(at Weeks 4, 8 and 12)
- C-peptide(at Weeks 4, 8 and 12)
- Total Cholesterol(at Weeks 4, 8 and 12)
- LDL-c(at Weeks 4, 8 and 12)
- HDL-c(at Weeks 4, 8 and 12)
- Adverse Events (AE)(Over 12 weeks)
- Serum Triglycerides(at Weeks 4, 8 and 12)
- Body Weight(at Weeks 4, 8 and 12)
- Waist Circumference(at Weeks 4, 8 and 12)
- Safety endpoints include AEs, incidence of urinary tract infections, incidence of genital fungal infections, vital signs, ECGs and standard laboratory tests(12 weeks)
研究者
研究点 (19)
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