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

August 9, 2013 updated by: AstraZeneca

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Anjyo, Japan
        • Research Site
      • Bunkyo-ku, Japan
        • Research Site
      • Chuo-ku, Japan
        • Research Site
      • Daito, Japan
        • Research Site
      • Kamagaya, Japan
        • Research Site
      • Kashiwara, Japan
        • Research Site
      • Matsuyama, Japan
        • Research Site
      • Nagoya, Japan
        • Research Site
      • Naka, Japan
        • Research Site
      • Nakano-ku, Japan
        • Research Site
      • Nerima-ku, Japan
        • Research Site
      • Okinawa, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Sapporo, Japan
        • Research Site
      • Shibuya-ku, Japan
        • Research Site
      • Shinjyuku-ku, Japan
        • Research Site
      • Suita, Japan
        • Research Site
      • Uji, Japan
        • Research Site
      • Wakayama, Japan
        • Research Site
      • Yamato, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 5
Placebo
Drug: Placebo
once daily, 12 weeks
Experimental: 1
1mg dapagliflozin
Drug: Dapagliflozin
once daily, 12 weeks
Experimental: 2
2.5mg dapagliflozin
Drug: Dapagliflozin
once daily, 12 weeks
Experimental: 3
5mg dapagliflozin
Drug: Dapagliflozin
once daily, 12 weeks
Experimental: 4
10mg dapagliflozin
Drug: Dapagliflozin
once daily, 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change in HbA1c Levels
Time Frame: 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.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change in Fasting Plasma Glucose
Time Frame: 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.
Baseline to Week 12
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Time Frame: At Week 12
Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy
At Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Parikh Shamik, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 31, 2009

First Submitted That Met QC Criteria

September 3, 2009

First Posted (Estimate)

September 4, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1692C00005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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