A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 279
- 主要终点
- Change in HbA1c From Baseline to Week 18
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.
详细描述
This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study doctor will know the identity of assigned study drug), placebo-controlled, parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical in appearance to canagliflozin but does not contain active drug) in patients with type 2 diabetes mellitus (T2DM) who are not achieving an adequate response from current antihyperglycemic therapy with metformin to control their diabetes. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with T2DM. Patients will take single-blind placebo capsules orally (by mouth) for 2 weeks before randomization. Patients will be randomly assigned canagliflozin or matching placebo, orally, twice daily, with 1 capsule taken with the morning meal and 1 capsule taken with the evening meal (2 capsules per day) and concurrent with metformin, if applicable, for up to 18 weeks. The dosing time of metformin should remain the same throughout 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must have a diagnosis of T2DM and be currently treated with metformin
- •Patients in the study must have a HbA1c between >=7 and <=10.5%
- •Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)
排除标准
- •History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
研究组 & 干预措施
Placebo
Each patient will receive matching placebo twice daily for 18 weeks
干预措施: Placebo (Drug)
Canagliflozin 50 mg bid
Each patient will receive 50 mg canagliflozin twice daily for 18 weeks.
干预措施: Canagliflozin 50 mg (Drug)
Canagliflozin 50 mg bid
Each patient will receive 50 mg canagliflozin twice daily for 18 weeks.
干预措施: Metformin (Drug)
Canagliflozin 150 mg bid
Each patient will receive 150 mg canagliflozin twice daily for 18 weeks
干预措施: Canagliflozin 150 mg (Drug)
Canagliflozin 150 mg bid
Each patient will receive 150 mg canagliflozin twice daily for 18 weeks
干预措施: Metformin (Drug)
Placebo
Each patient will receive matching placebo twice daily for 18 weeks
干预措施: Metformin (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 18
时间窗: Day 1 (Baseline) and Week 18
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
次要结局
- Percentage of Patients With HbA1c <7% at Week 18(Week 18)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18(Day 1 (Baseline) and Week 18)
- Percent Change in Body Weight From Baseline to Week 18(Day 1 (Baseline) and Week 18)