Conditions: Type 2 Diabetes Mellitus
Keywords: Japanese patients with type 2 diabetes with inadequate glycemic control on insulin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 266
Healthy volunteers: no

Brief summary:
Japanese male and female patients with Type 2 Diabetes and aged ≥ 20 years old, with inadequate glycemic control on insulin defined as Haemoglobin A1c ≥ 7.2% and \< 11% will be enrolled into the wash-out phase or directly into the lead-in phase depending on whether the patient has been receiving an Oral antidiabetic drug (including Glucagon-Like Peptide-1 agonists and excluding Thiazolidinedions) other than a Dipeptidyl Peptidase-4 inhibitor as part of the baseline treatment. Additional treatment with a concomitant Dipeptidyl Peptidase-4 inhibitor is allowed. And around 180 eligible patients in total will be randomized into the study with a 2:1 randomization scheme (i.e.120 patients into the dapagliflozin treatment group and 60 patients into the placebo treatment group. All subjects who completed a 16 weeks double-blind treatment period will shift to a 36 weeks open extension treatment period.

Detailed description:

Arms:
arm 1: dapagliflozin tablet 5mg arm 2: dapagliflozin tablet 5mg placebo

Interventions: intervention 1: Dapagliflozin 5 mg intervention 2: Placebo tablet
Intervention descriptions: intervention 1: Dapagliflozin, a blood glucose lowering drug. Oral dose intervention 2: Placebo tablet. Oral dose

Protocol document: