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

This study has been completed.
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: August 31, 2009
Last updated: August 9, 2013
Last verified: August 2013
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Dapagliflozin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

  • 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

Enrollment: 417
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: 5
Drug: Placebo
once daily, 12 weeks


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00972244

Research Site
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
Nakano-ku, Japan
Research Site
Naka, 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
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Parikh Shamik AstraZeneca
  More Information

Responsible Party: AstraZeneca Identifier: NCT00972244     History of Changes
Other Study ID Numbers: D1692C00005
Study First Received: August 31, 2009
Results First Received: January 21, 2013
Last Updated: August 9, 2013

Keywords provided by AstraZeneca:
Type 2 diabetes mellitus
phase 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on May 25, 2017