A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 218
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
研究概览
简要总结
The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.
详细描述
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a study drug, to test whether the study drug has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally or near-maximally effective doses of metformin >=1500 mg/day and sitagliptin 100 mg/day. Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1 ratio for 26 weeks. During the study the participants will be also provided with diet and exercise counseling (standardized non-pharmacological therapy).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of type 2 diabetes mellitus
- •Must have a screening HbA1c of >=7.5% to <=10.5%
- •Must be on metformin >=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening
排除标准
- •History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption or primary renal glycosuria
- •A myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening
- •eGFR <60 ml/min/1.73m2, or serum creatinine >=1.4 mg/dL for men and >=1.3 mg/dL for women
- •Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis)
- •Major surgery (ie, requiring general anesthesia) within 12 weeks before screening
研究组 & 干预措施
Canagliflozin (JNJ-28431754)
Each participant will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 6 weeks, then the dose may be increased to 300 mg once daily.
干预措施: Canagliflozin, 100 mg (Drug)
Canagliflozin (JNJ-28431754)
Each participant will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 6 weeks, then the dose may be increased to 300 mg once daily.
干预措施: Canagliflozin, 300 mg (Drug)
Placebo
Each participant will receive placebo (inactive medication) once daily for 28 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
时间窗: Baseline and Week 26
次要结局
- Percent Change From Baseline in Body Weight at Week 26(Baseline and Week 26)
- Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26(Week 26)
- Change From Baseline in Systolic Blood Pressure (SBP) at Week 26(Baseline and Week 26)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26(Baseline and Week 26)