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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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01392677
First received: July 11, 2011
Last updated: February 11, 2014
Last verified: February 2014

July 11, 2011
February 11, 2014
October 2011
January 2013   (final data collection date for primary outcome measure)
Adjusted Mean Change From Baseline in HbA1c Levels [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
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.
Change in HbA1c from baseline to week 24 [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01392677 on ClinicalTrials.gov Archive Site
  • Adjusted Mean Change From Baseline in FPG [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo
  • Change in fasting plasma glucose from baseline to week 24 [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in total body weight from baseline to week 24 [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving a therapeutic glycaemic response, defined as HbA1c <7.0% at week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change in seated systolic blood pressure (SBP) from baseline to week 8 [ Time Frame: from baseline to week 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in FPG to week 8 between dapagliflozin and placebo [ Time Frame: From baseline to week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in seated SBP to week 24 between dapagliflozin and placebo. [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in HOMA-2, HOMA-IR to week 24 between dapagliflozin and placebo. [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in insulin, proinsulin and C-peptide values to week 24 between dapagliflozin and placebo [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in waist circumference to week 24 between dapagliflozin and placebo. [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

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 Mellitus
  • High HbA1c Level
  • Inadequate Glycaemic Control
  • 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
  • Experimental: Dapagliflozin 10 mg tablet
    Intervention: Drug: dapagliflozin
  • Placebo Comparator: matching placebo tablet
    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
311
August 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Germany,   Poland,   Slovakia,   Spain
 
NCT01392677
D1693C00005
No
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
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
AstraZeneca
February 2014

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