At a glance
ClinicalIndex Comparison Record- ✓Type 1 diabetes mellitus diagnosed for at least 1 year
- ✓Inadequate glycemic control with HbA1c 7.0% to 9.0% on basal-bolus insulin at screening
- ✓Body mass index 21 to 35 kg/m² inclusive
- ✓Total daily insulin dose ≥0.6 IU/kg at screening
- ✕History of type 2 diabetes mellitus
- ✕History of pancreas or β-cell transplantation
- ✕Diabetes secondary to pancreatitis or pancreatectomy
- ✕Severe hypoglycemia requiring assistance from another person, seizure, or loss of consciousness within 6 months prior to study start
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Canagliflozin 100 mg, Canagliflozin 300 mg, and 1 other intervention for Diabetes Mellitus, Type 1. Completed, enrolled 352 participants across 53 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.
Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.
Matching placebo capsule will be taken orally, before the first meal of the day.