A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 18-Week 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 Alone or in Combination With a Sulphonylurea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 678
- 主要终点
- Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea.
详细描述
This is a double-blind (neither study staff or the patient will know the identity of the treatment assigned) study of canagliflozin where Chinese and other Asian adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control on metformin alone or in combination with a sulphonylurea (SU) will be randomized (assigned to 1 of 3 treatments by chance) to receive the addition of treatment with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, or matching placebo capsules (placebo is a treatment identical in appearance to canagliflozin but does not contain active drug). All patients will take orally (by mouth) 1 single-blind placebo capsule once daily before the first meal of the day for up to 2 weeks (last dose of single-blind placebo to be taken the day before the baseline (Day 1) visit. On Day 1, patients will take orally, once daily 1 capsule of canagliflozin 100 mg, canagliflozin 300 mg, or placebo before the first meal of the day for up to 18 weeks.
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, Care Provider)
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
- •Patients with T2DM with inadequate glycemic control on metformin monotherapy or on metformin in combination with an SU at protocol-specified doses and having HbA1c >=7.0% and <=10.5% at Week -2 are eligible for enrollment in the study.
排除标准
- •History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- •Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements >=270 mg/dL (15 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
- •History of a severe hypoglycemic episode within 6 months before screening
- •History of or current illness considered to be clinically significant by the investigator
研究组 & 干预措施
Canagliflozin 300mg
Each participant will receive 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
干预措施: Metformin (Drug)
Canagliflozin 100mg
Each participant will receive 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
干预措施: Canagliflozin 100mg (Drug)
Canagliflozin 100mg
Each participant will receive 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
干预措施: Metformin (Drug)
Canagliflozin 100mg
Each participant will receive 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
干预措施: Sulphonylurea (Drug)
Canagliflozin 300mg
Each participant will receive 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
干预措施: Canagliflozin 300mg (Drug)
Canagliflozin 300mg
Each participant will receive 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
干预措施: Sulphonylurea (Drug)
Placebo
Each participant will receive matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
干预措施: Placebo (Drug)
Placebo
Each participant will receive matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
干预措施: Metformin (Drug)
Placebo
Each participant will receive matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
干预措施: Sulphonylurea (Drug)
结局指标
主要结局
Change in Glycosylated Hemoglobin (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
- Percent Change in Body Weight From Baseline to Week 18(Day 1 (Baseline) and Week 18)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18(Day 1 (Baseline) and Week 18)
- Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18(Day 1 (Baseline) and Week 18)
- Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18(Day 1 (Baseline) and Week 18)