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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus; Cardiovascular Disease; Inadequate Glycaemic Control	Drug: Dapagliflozin; Drug: Placebo	Phase 3

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	964 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official 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
Study Start Date :	March 2010
Actual Primary Completion Date :	May 2011
Actual Study Completion Date :	December 2012

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	45 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 135 Study Locations

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Principal Investigator:	Dr. Lawrence A Leiter, MD	Division of Endocrinology & Metabolism, St Michael's Hospital

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01042977 History of Changes
Other Study ID Numbers:	D1690C00019
First Posted:	January 6, 2010
Results First Posted:	August 23, 2013
Last Update Posted:	February 17, 2014
Last Verified:	December 2013

Keywords provided by AstraZeneca:

dapagliflozin; diabetes; cardiovascular disease

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Cardiovascular Diseases	Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases