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

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ClinicalTrials.gov Identifier: NCT00972244
Recruitment Status : Completed
First Posted : September 4, 2009
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE August 31, 2009
First Posted Date  ICMJE September 4, 2009
Results First Submitted Date  ICMJE January 21, 2013
Results First Posted Date  ICMJE October 14, 2013
Last Update Posted Date October 14, 2013
Study Start Date  ICMJE August 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
Mean changes from baseline in glycosylated hemoglobin [ Time Frame: After 12 weeks of double-blind therapy. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
  • Change from baseline in fasting plasma glucose [ Time Frame: After 12 weeks of double-blind therapy. ]
  • Proportion of subjects achieving therapeutic glycemic response defined as glycosylated hemoglobin< 7% [ Time Frame: After 12 weeks of double-blind therapy. ]
  • Safety and tolerability of dapagliflozin [ Time Frame: Through completion of the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Dapagliflozin
    once daily, 12 weeks
  • Drug: Placebo
    once daily, 12 weeks
Study Arms  ICMJE
  • Experimental: 1
    1mg dapagliflozin
    Intervention: Drug: Dapagliflozin
  • Experimental: 2
    2.5mg dapagliflozin
    Intervention: Drug: Dapagliflozin
  • Experimental: 3
    5mg dapagliflozin
    Intervention: Drug: Dapagliflozin
  • Experimental: 4
    10mg dapagliflozin
    Intervention: Drug: Dapagliflozin
  • Placebo Comparator: 5
    Placebo
    Intervention: Drug: Placebo
Publications * Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2011)
417
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2009)
275
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972244
Other Study ID Numbers  ICMJE D1692C00005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Parikh Shamik AstraZeneca
PRS Account AstraZeneca
Verification Date August 2013

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