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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00972244
First received: August 31, 2009
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Placebo
Drug: Placebo
once daily, 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972244

Locations
Japan
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
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
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Parikh Shamik AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov 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
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Type 2 diabetes mellitus
Japanese
phase 2
efficacy
safety
dapagliflozin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014