NCT01294423

Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

Conditions

• Type 2 Diabetes
• High Blood Sugar

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
DRUG	Dapagliflozin	Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
DRUG	Placebo	Matching placebo for Dapagliflozin 5mg/10mg oral dose

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-02-11
• Last updated: 2014-07-24
• Results posted: 2013-08-23

Locations

26 sites across 1 country: Japan