Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Dapagliflozin; Drug: Placebo

• Registration Number: NCT00972244
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2013-01-21
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-09
• Last Update Submitted: 2013-08-09
• Results First Posted: 2013-10-14
• Last Update Posted: 2013-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 417

Inclusion Criteria

• Japanese Subjects with type 2 diabetes mellitus.
• Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
• Provision of informed consent.

Exclusion Criteria

• Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
• The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	Dapagliflozin	10mg dapagliflozin
5	Placebo	Placebo
3	Dapagliflozin	5mg dapagliflozin
1	Dapagliflozin	1mg dapagliflozin
2	Dapagliflozin	2.5mg dapagliflozin

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change in HbA1c Levels	Baseline to Week 12	The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.

Secondary Outcome Measures

Name	Time	Method
Adjusted Mean Change in Fasting Plasma Glucose	Baseline to Week 12	Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%	At Week 12	Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin \<7%, after 12 weeks of double-blind therapy

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamato, Japan