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Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

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ClinicalTrials.gov Identifier: NCT01392677
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : December 27, 2013
Last Update Posted : March 12, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE July 11, 2011
First Posted Date  ICMJE July 12, 2011
Results First Submitted Date  ICMJE November 5, 2013
Results First Posted Date  ICMJE December 27, 2013
Last Update Posted Date March 12, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
Adjusted Mean Change From Baseline in HbA1c Levels [ Time Frame: Baseline to week 24 ]
To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
Change in HbA1c from baseline to week 24 [ Time Frame: From baseline to week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
  • Adjusted Mean Change From Baseline in FPG [ Time Frame: Baseline to week 24 ]
    To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo
  • Adjusted Mean Change From Baseline in Total Body Weight [ Time Frame: Baseline to week 24 ]
    To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo
  • Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF) [ Time Frame: Baseline to week 24 ]
    To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo
  • Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure [ Time Frame: Baseline to week 8 ]
    To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
  • Change in fasting plasma glucose from baseline to week 24 [ Time Frame: from baseline to week 24 ]
  • Change in total body weight from baseline to week 24 [ Time Frame: from baseline to week 24 ]
  • Proportion of patients achieving a therapeutic glycaemic response, defined as HbA1c <7.0% at week 24 [ Time Frame: Week 24 ]
  • Change in seated systolic blood pressure (SBP) from baseline to week 8 [ Time Frame: from baseline to week 8 ]
  • Proportion of patients discontinued for lack of efficacy or rescued for failing to maintain FPG below pre-specified rescue criteria at weeks 4, 8, 16 and 24 between dapagliflozin and placebo. [ Time Frame: At weeks 4,8,16,24 ]
  • Change from baseline in HbA1c to week 24 between dapagliflozin and placebo in patients with baseline HbA1c ≥8.0 %. [ Time Frame: From baseline to week 24 ]
  • Change from baseline in HbA1c to week 24 between dapagliflozin and placebo in patients with baseline HbA1c ≥9.0%. [ Time Frame: From baseline to week 24 ]
  • Change from baseline in FPG to week 8 between dapagliflozin and placebo [ Time Frame: From baseline to week 8 ]
  • Change from baseline in seated SBP to week 24 between dapagliflozin and placebo. [ Time Frame: From baseline to week 24 ]
  • Proportion of patients who achieve seated BP of <130/80mmHg at week 24 in patients with baseline elevated blood pressure (BP) (baseline SBP ≥130 mmHg and/or baseline diastolic blood pressure (DBP) ≥80mmHg). [ Time Frame: Week 24 ]
  • Percent change from baseline in fasting lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides) to week 24 between dapagliflozin and placebo. [ Time Frame: From baseline to week 24 ]
  • Change from baseline in HOMA-2, HOMA-IR to week 24 between dapagliflozin and placebo. [ Time Frame: From baseline to week 24 ]
  • Change from baseline in insulin, proinsulin and C-peptide values to week 24 between dapagliflozin and placebo [ Time Frame: From baseline to week 24 ]
  • Change from baseline in waist circumference to week 24 between dapagliflozin and placebo. [ Time Frame: From baseline to week 24 ]
  • Effect of dapagliflozin versus placebo from baseline to week 24 on health-related quality of life (HRQL) as measured by Euro quality of life 5 Dimensions 3 Levels (EQ-5D-3L). [ Time Frame: From baseline to week 24 ]
  • Scores of treatment satisfaction, individual satisfaction and perceived frequency of hyper/hypoglycaemia as measured by Diabetes Treatment Satisfaction Questionnaire status (DTSQs) observed with dapagliflozin vs. placebo from baseline to wk 24 and wk 52. [ Time Frame: From baseline to week 24 and week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea
Official Title  ICMJE A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea
Brief Summary This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • High HbA1c Level
  • Inadequate Glycaemic Control
Intervention  ICMJE
  • Drug: dapagliflozin
    10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
  • Drug: placebo
    matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period
Study Arms  ICMJE
  • Experimental: Dapagliflozin 10 mg tablet
    Intervention: Drug: dapagliflozin
  • Placebo Comparator: matching placebo tablet
    Intervention: Drug: placebo
Publications * Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S; Study 05 Group. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Diabetes Care. 2015 Mar;38(3):365-72. doi: 10.2337/dc14-0666. Epub 2015 Jan 15.

*   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: February 11, 2014)
311
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2011)
216
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Men or women age ≥ 18 years old
  • Stable dose combination of metformin and sulfonylurea
  • HbA1c ≥7.7% and ≤11.0%

Exclusion Criteria:

  • Type 1 diabetes mellitus or diabetes insipidus
  • Recent cardiovascular events
  • Kidney or urological disorders
  • Hepatic disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Canada,   Czech Republic,   Germany,   Poland,   Slovakia,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01392677
Other Study ID Numbers  ICMJE D1693C00005
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: Eva Johnsson, PhD, Medical Science Director AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden
Principal Investigator: Stephan Matthaei, Prof.Dr.med Diabetes-Zentrum Quakenbruck
PRS Account AstraZeneca
Verification Date February 2014

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