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 17, 2014
Last verified: July 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
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 17, 2014
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 September 18, 2014