Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type 1 Canagliflozin Continuous Glucose Monitoring
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 352
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: Each participant will receive 100 mg of canagliflozin once daily for 18 weeks. arm 2: Each participant will receive 300 mg of canagliflozin once daily for 18 weeks. arm 3: Each participant will receive matching placebo once daily for 18 weeks

Interventions: intervention 1: Canagliflozin 100 mg intervention 2: Canagliflozin 300 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day. intervention 2: Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day. intervention 3: Matching placebo capsule will be taken orally, before the first meal of the day.

Protocol document: