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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: September 25, 2012
Last verified: March 2012
History of Changes

February 10, 2011
September 25, 2012
February 2011
March 2012   (final data collection date for primary outcome measure)
change in haemoglobin A1c (HbA1c) [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01294423 on ClinicalTrials.gov Archive Site
  • change in Fasting plasma glucose(FPG) [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
  • change in total body weight [ Time Frame: From Baseline to Week24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus
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

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 Type2 diabetes mellitus who have inadequate glycemic control with diet and exercise.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • High Blood Sugar
  • Drug: Dapagliflozin
    Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
  • Drug: Dapagliflozin
    Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
  • Drug: Placebo
    Matching placebo for Dapagliflozin 5mg/10mg oral dose
  • Experimental: 1
    Dapagliflozin 5 mg
    Intervention: Drug: Dapagliflozin
  • Experimental: 2
    Dapagliflozin 10 mg
    Intervention: Drug: Dapagliflozin
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
261
March 2012
March 2012   (final data collection date for primary outcome measure)

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 type2 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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01294423
D1692C00006
No
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Study Director: Jisin Yang, MD AstraZeneca KK
AstraZeneca
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP