A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 571
- 试验地点
- 106
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
研究概览
简要总结
Primary Objective:
To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs).
Secondary Objectives:
- To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c.
- To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP.
- To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.
详细描述
Up to 60 weeks (Screening phase of up to 2 weeks, a 4-week Lantus titration/single-blind placebo Run-in phase), a 52-week double blind Treatment Period, and a 2-week post-treatment Follow-up Period.
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 —（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
Placebo
Following a 4-week run-in period, participants were randomized to matching placebo to sotagliflozin 200 milligrams (mg) administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
干预措施: Insulin glargine (HOE901) (Drug)
Placebo
Following a 4-week run-in period, participants were randomized to matching placebo to sotagliflozin 200 milligrams (mg) administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
干预措施: Placebo (Drug)
Placebo
Following a 4-week run-in period, participants were randomized to matching placebo to sotagliflozin 200 milligrams (mg) administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
干预措施: Oral Antidiabetes Drugs (OADs) (Drug)
Sotagliflozin 200 mg
Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
干预措施: Sotagliflozin (Drug)
Sotagliflozin 200 mg
Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
干预措施: Insulin glargine (HOE901) (Drug)
Sotagliflozin 200 mg
Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
干预措施: Placebo (Drug)
Sotagliflozin 200 mg
Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
干预措施: Oral Antidiabetes Drugs (OADs) (Drug)
Sotagliflozin 400 mg
Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
干预措施: Sotagliflozin (Drug)
Sotagliflozin 400 mg
Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
干预措施: Insulin glargine (HOE901) (Drug)
Sotagliflozin 400 mg
Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
干预措施: Oral Antidiabetes Drugs (OADs) (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
时间窗: Baseline and Week 18
An analysis of covariance (ANCOVA) model was used for the analysis.
次要结局
- Change From Baseline in HbA1c at Week 52(Baseline and Week 52)
- Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12(Baseline and Week 12)
- Percentage of Participants With Adverse Events (AEs)(First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks)
- Change From Baseline in SBP at Week 12 for All Participants(Baseline to Week 12)
- Change From Baseline in Body Weight at Week 52(Baseline and Week 52)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18(Baseline and Week 18)
- Change From Baseline in Body Weight at Week 18(Baseline and Week 18)