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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01031680
First received: December 10, 2009
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients 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, cardiovascular disease and hypertension.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Cardiovascular Disease
Hypertension
Inadequate Glycaemic Control
Drug: Dapagliflozin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who Exhibit Inadequate Glycaemic Control on Usual Care

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 and hypertension, 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 and hypertension 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.


Secondary Outcome Measures:
  • Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) [ 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 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.

  • Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) 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.

  • 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.


Enrollment: 922
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dapagliflozin 10 mg tablet
Drug: Dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
Placebo Comparator: 2
Matching placebo tablet
Drug: Placebo
Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus.
  • Cardiovascular disease
  • Hypertension

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031680

  Show 141 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Principal Investigator: Dr. William Cefalu Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01031680     History of Changes
Other Study ID Numbers: D1690C00018
Study First Received: December 10, 2009
Results First Received: January 21, 2013
Last Updated: September 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
dapagliflozin
diabetes
cardiovascular disease
hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014