Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01042977
First received: January 5, 2010
Last updated: December 18, 2013
Last verified: December 2013

January 5, 2010
December 18, 2013
March 2010
May 2011   (final data collection date for primary outcome measure)
  • Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24.
  • Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.
  • Mean change in HbA1c from baseline to week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of responders meeting all criteria of a 3-item endpoint of clinical benefit after 24 weeks with a reduction in HbA1c of of 0.5% or more, in body weight of 3% or more, and in systolic blood pressure of 3 mmHg or more from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01042977 on ClinicalTrials.gov Archive Site
  • Adjusted Mean Percent Change in Body Weight [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.
  • Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m² [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.
  • Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.
  • Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.
  • Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8.
  • Mean percent change in body weight from baseline to week 24, and proportion of patients with BMI ≥27 kg/m2 with a 5% or more loss of body weight to week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean change in systolic blood pressure from baseline to week 8 and to week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in systolic blood pressure in patients with baseline systolic blood pressure ≥130 mm Hg from baseline to week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
A 24-week, Multicentre, Randomised, Double-blind,Age-stratified, Placebo Controlled Phase III Study With an 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Patients With T2DM and Cardiovascular Disease, Who Exhibit Inadequate Glycaemic Control on Usual Care

This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular disease

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
  • Cardiovascular Disease
  • Inadequate Glycaemic Control
  • Drug: Dapagliflozin
    10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
  • Drug: Placebo
    matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
  • Experimental: 1
    dapagliflozin 10 mg tablet
    Intervention: Drug: Dapagliflozin
  • Placebo Comparator: 2
    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
964
December 2012
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes mellitus.
  • Cardiovascular disease
  • Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment

Exclusion Criteria:

  • Patients with type 1 diabetes or diabetes insipidus
  • Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
  • Any clinically significant illness, which would compromise the patient's safety and their participation in the study
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Poland,   Argentina,   Australia,   Austria,   Bulgaria,   Canada,   Chile,   Germany,   Hungary
 
NCT01042977
D1690C00019
Not Provided
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Principal Investigator: Dr. Lawrence A Leiter, MD Division of Endocrinology & Metabolism, St Michael's Hospital
AstraZeneca
December 2013

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