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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01294423
First received: February 10, 2011
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
High Blood Sugar
Drug: Dapagliflozin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adjusted Mean Change in HbA1c Levels [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.


Secondary Outcome Measures:
  • Adjusted Mean Change in Fasting Plasma Glucose (FPG) [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

  • Adjusted Mean Change in Body Weight [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.


Enrollment: 261
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dapagliflozin 5 mg
Drug: Dapagliflozin
Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
Experimental: 2
Dapagliflozin 10 mg
Drug: Dapagliflozin
Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
Placebo Comparator: 3 Drug: Placebo
Matching placebo for Dapagliflozin 5mg/10mg oral dose

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • FPG >240 mg/dL before randomization
  • Subjects who have history of unstable or rapidly progressing renal disease
  • Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
  • Significant cardiovascular history
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294423

Locations
Japan
Research Site
Noda, Chiba, Japan
Research Site
Yukuhashi, Fukuoka, Japan
Research Site
Hiroshima-shi, Hiroshima, Japan
Research Site
Chitose-shi, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Takasago-shi, Hyogo, Japan
Research Site
Hakusan-shi, Ishikawa, Japan
Research Site
Sanuki-shi, Kagawa, Japan
Research Site
Takamatsu-shi, Kagawa, Japan
Research Site
Ebina-shi, Kanagawa, Japan
Research Site
Kamakura-shi, Kanagawa, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Sendai-shi, Miyagi, Japan
Research Site
Matsumoto-shi, Nagano, Japan
Research Site
Osaka-shi, Osaka, Japan
Research Site
Suita, Osaka, Japan
Research Site
Otsu-shi, Shiga, Japan
Research Site
Shizuoka-shi, Shizuoka, Japan
Research Site
Chuo, Tokyo, Japan
Research Site
Chuo-ku, Tokyo, Japan
Research Site
Meguro-ku,, Tokyo, Japan
Research Site
Ota-ku, Tokyo, Japan
Research Site
Takaoka-shi, Toyama, Japan
Research Site
Toyama-shi, Toyama, Japan
Research Site
Fukuoka, Japan
Research Site
Okayama, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Jisin Yang, MD AstraZeneca KK
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01294423     History of Changes
Other Study ID Numbers: D1692C00006
Study First Received: February 10, 2011
Results First Received: January 30, 2013
Last Updated: July 19, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase3
Clinical trial
Type2 Diabetes Mellitus

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

ClinicalTrials.gov processed this record on April 23, 2014