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OpenTrials
Completed

NCT Number: NCT01042977

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Inadequate Glycaemic Control Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Buenos Aires F.D., Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period

Placebo

Drug

matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period

Primary outcomes

  1. Adjusted Mean Change in HbA1c Levels

    Time frame: Baseline to Week 24

    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.

  2. Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit

    Time frame: Baseline to Week 24

    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.

Secondary outcomes

  1. Adjusted Mean Percent Change in Body Weight

    Time frame: Baseline to Week 24

    To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.

  2. 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

    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.

  3. Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)

    Time frame: Baseline to Week 8

    To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.

  4. Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF)

    Time frame: Baseline to Week 24

    To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jan 6, 2010
Registry last updated
Feb 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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