Conditions: Type 1 Diabetes Mellitus
Keywords: Dapagliflozin Efficacy Safety Add on to insulin Oral Antidiabetic Type 1 diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 833
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

Detailed description:
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Arms:
arm 1: Dapagliflozin 5 mg tablet orally, once daily for 52 weeks arm 2: Dapagliflozin 10 mg tablet orally, once daily for 52 weeks arm 3: Placebo tablet orally, once daily for 52 weeks

Interventions: intervention 1: Dapagliflozin intervention 2: Placebo for dapagliflozin
Intervention descriptions: intervention 1: Tablets intervention 2: Tablets

Protocol document: