A Randomized Phase 2, Double-blind, Placebo-controlled, Treat-to-Target, Parallel-group, 3-arm, Multicenter Study to Assess the Efficacy and Safety of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Subjects With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 352
- 主要终点
- Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight
研究概览
简要总结
The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).
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 medication to test whether the medication has a real effect) parallel-group, multicenter study of canagliflozin as an addition to insulin therapy for participants with type 1 diabetes mellitus and inadequate glycemic control.
Approximately 330 participants will be randomly assigned in a 1:1:1 ratio to either canagliflozin 100 mg, canagliflozin 300 mg, or placebo groups. About 90 participants (30 per treatment group) will be selected for a substudy with a purpose of a continuous glucose monitoring (CGM) assessment for 7 days at baseline and 7 days at the end of treatment.
The total duration of the participation will be about 22 weeks, during which participants will need to return to investigational sites for approximately 9 visits. During the study participants will receive advice on treatment of hypoglycemia and diabetic ketoacidosis (DKA), as well as on compliance with diet and exercise.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have type 1 diabetes mellitus (T1DM) for at least 1 year
- •Must have have inadequate glycemic control (as defined by glycosylated hemoglobin level of >= 7.0% to <= 9.0%) on basal plus bolus insulin at screening
- •Must have body mass index 21 to 35 kg/m2 inclusive
- •Must be on a total daily dose of insulin >= 0.6 IU/kg at screening
- •Must be on a stable insulin regimen for at least 8 weeks prior to screening
排除标准
- •History of T2DM, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- •Severe hypoglycemia (defined as an event required assistance from another person, or which resulted in seizure or loss of consciousness) within 6 months prior to study start
- •Diabetic ketoacidosis within 6 months prior to study start
- •History of hereditary glucose-galactose malabsorption or primary renal glycosuria
- •An ongoing, inadequately controlled thyroid disorder
研究组 & 干预措施
Canagliflozin 100 mg
Each participant will receive 100 mg of canagliflozin once daily for 18 weeks.
干预措施: Canagliflozin 100 mg (Drug)
Canagliflozin 300 mg
Each participant will receive 300 mg of canagliflozin once daily for 18 weeks.
干预措施: Canagliflozin 300 mg (Drug)
Placebo
Each participant will receive matching placebo once daily for 18 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight
时间窗: Week 18
Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight.
Percentage of Participants With Adverse Events
时间窗: Up to 22 Weeks
次要结局
未报告次要终点