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

NCT01042977 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 964

Last updated 2014-02-17

Study results available
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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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Dr. Lawrence A Leiter, MD · Division of Endocrinology & Metabolism, St Michael's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-05-31
Completion
2012-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Chile
  • Germany
  • Hungary
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01042977 on ClinicalTrials.gov