Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea
February 11, 2014 updated by: AstraZeneca
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
311
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada
- Research Site
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Alberta
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Edmonton, Alberta, Canada
- Research Site
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Manitoba
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Winnipeg, Manitoba, Canada
- Research Site
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada
- Research Site
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Research Site
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Sydney Mines, Nova Scotia, Canada
- Research Site
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Ontario
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Brampton, Ontario, Canada
- Research Site
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Etobicoke, Ontario, Canada
- Research Site
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Markham, Ontario, Canada
- Research Site
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Smiths Falls, Ontario, Canada
- Research Site
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Prince Edward Island
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Kensington, Prince Edward Island, Canada
- Research Site
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Quebec
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Laval, Quebec, Canada
- Research Site
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Beroun, Czech Republic
- Research Site
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Ceske Budejovice, Czech Republic
- Research Site
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Jilove U Prahy, Czech Republic
- Research Site
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Praha, Czech Republic
- Research Site
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Praha 5, Czech Republic
- Research Site
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Praha 6, Czech Republic
- Research Site
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Semily, Czech Republic
- Research Site
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Vyskov, Czech Republic
- Research Site
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Asslar, Germany
- Research Site
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Aßlar, Germany
- Research Site
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Berlin, Germany
- Research Site
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Dresden, Germany
- Research Site
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Falkensee, Germany
- Research Site
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Neuwied, Germany
- Research Site
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Pirna, Germany
- Research Site
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Kielce, Poland
- Research Site
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Lodz, Poland
- Research Site
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Lublin, Poland
- Research Site
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Poznan, Poland
- Research Site
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Poznań, Poland
- Research Site
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Warszawa, Poland
- Research Site
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Zgierz, Poland
- Research Site
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Łódź, Poland
- Research Site
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Banska Bystrica, Slovakia
- Research Site
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Kosice, Slovakia
- Research Site
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Povazska Bystrica, Slovakia
- Research Site
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Rimavska Sobota, Slovakia
- Research Site
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A Coruña, Spain
- Research Site
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Barcelona, Spain
- Research Site
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Oviedo, Spain
- Research Site
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Sta Coloma de Gramenet (BCN), Spain
- Research Site
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Asturias
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Oviedo, Asturias, Spain
- Research Site
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Catalu?a
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Sta Coloma de Gramanet (bcn), Catalu?a, Spain
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Cataluna
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Barcelona, Cataluna, Spain
- Research Site
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Galicia
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A Coruna, Galicia, Spain
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetes mellitus
- Men or women age ≥ 18 years old
- Stable dose combination of metformin and sulfonylurea
- HbA1c ≥7.7% and ≤11.0%
Exclusion Criteria:
- Type 1 diabetes mellitus or diabetes insipidus
- Recent cardiovascular events
- Kidney or urological disorders
- Hepatic disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Dapagliflozin 10 mg tablet
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10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
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Placebo Comparator: matching placebo tablet
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matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Adjusted Mean Change From Baseline in HbA1c Levels
Time Frame: Baseline to week 24
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To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.
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Baseline to week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Adjusted Mean Change From Baseline in FPG
Time Frame: Baseline to week 24
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To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo
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Baseline to week 24
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Adjusted Mean Change From Baseline in Total Body Weight
Time Frame: Baseline to week 24
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To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo
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Baseline to week 24
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Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)
Time Frame: Baseline to week 24
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To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo
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Baseline to week 24
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Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure
Time Frame: Baseline to week 8
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To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo
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Baseline to week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Eva Johnsson, PhD, Medical Science Director, AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden
- Principal Investigator: Stephan Matthaei, Prof.Dr.med, Diabetes-Zentrum Quakenbruck
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
July 11, 2011
First Submitted That Met QC Criteria
July 11, 2011
First Posted (Estimate)
July 12, 2011
Study Record Updates
Last Update Posted (Estimate)
March 12, 2014
Last Update Submitted That Met QC Criteria
February 11, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1693C00005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.