- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00660907
Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients
March 10, 2015 updated by: AstraZeneca
A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1217
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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Buenos Aires, Argentina
- Research Site
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Caba, Argentina
- Research Site
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Capital Federal, Argentina
- Research Site
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Ciudad de Buenos Aires, Argentina
- Research Site
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Corrientes, Argentina
- Research Site
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Córdoba, Argentina
- Research Site
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La Plata, Argentina
- Research Site
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Rosario, Argentina
- Research Site
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Santa Fe, Argentina
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L'aigle, France
- Research Site
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Murs Erigne, France
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Nantes, France
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Nantes Cedex 1, France
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Paris, France
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Tours, France
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Vannes, France
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Bad Lauterberg, Germany
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Berlin, Germany
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Dresden, Germany
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Essen, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Heilbronn, Germany
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Ludwigshafen, Germany
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Mainz, Germany
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Pirna, Germany
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Schmiedeberg, Germany
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Wangen, Germany
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Perugia, Italy
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Pisa, Italy
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Roma, Italy
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Acapulco, Mexico
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Guadalajara, Mexico
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México, Mexico
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Veracruz, Mexico
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Den Haag, Netherlands
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Deurne, Netherlands
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Gorinchem, Netherlands
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Groningen, Netherlands
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Lichtenvoorde (gld), Netherlands
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Losser, Netherlands
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Poortvliet, Netherlands
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Rotterdam, Netherlands
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Wildervank, Netherlands
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Zutphen, Netherlands
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Cape Town, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Parow, South Africa
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Pretoria, South Africa
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Umkomaas, South Africa
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Witbank, South Africa
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Alicante, Spain
- Research Site
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Alzira (Valencia), Spain
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Barcelona, Spain
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Cornellá de Llobregat (BCN), Spain
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Madrid, Spain
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Sevilla, Spain
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Göteborg, Sweden
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Järfälla, Sweden
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Lund, Sweden
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Malmö, Sweden
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Skene, Sweden
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Stockholm, Sweden
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Södertälje, Sweden
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Umeå, Sweden
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Addlestone, United Kingdom
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Aylesbury, United Kingdom
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Bath, United Kingdom
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Bolton, United Kingdom
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Bury St Edmonds, United Kingdom
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Cookstown, United Kingdom
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Coventry, United Kingdom
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Ecclesfield, United Kingdom
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Edinburgh, United Kingdom
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Mortimer Reading, United Kingdom
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Trowbridge, United Kingdom
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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
- Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
- HbA1c >6.5% and </=10%
Exclusion Criteria:
- Type 1 Diabetes
- Insulin therapy within one year of enrolment
- Renal (kidney) failure or dysfunction
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: 1
dapagliflozin plus metformin
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Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
Other Names:
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Active Comparator: 2
glipizide plus metformin
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Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
Other Names:
Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
Other Names:
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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 in HbA1c Levels
Time Frame: Baseline to Week 52
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To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.
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Baseline to Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Adjusted Mean Change in Body Weight
Time Frame: Baseline to Week 52
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To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.
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Baseline to Week 52
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Proportion of Participants With at Least One Episode of Hypoglycemia
Time Frame: Baseline to Week 52
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To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events.
Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.
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Baseline to Week 52
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Proportion of Participants With Body Weight Reduction of at Least 5%
Time Frame: Baseline to Week 52
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To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline.
Least Squares Mean represents the percent of participants adjusted for baseline value.
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Baseline to Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael A. Nauck, Prof. Dr. med., Diabeteszentrum Bad Lauterberg, Germany
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.
General Publications
- Nauck MA, Del Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, Elze M, Parikh SJ. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011 Sep;34(9):2015-22. doi: 10.2337/dc11-0606. Epub 2011 Aug 4.
- Nauck M, del Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, Elze M, Parikh SJ. [Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S6-15. doi: 10.1055/s-0032-1305283. Epub 2013 Mar 25. German.
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
March 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
April 15, 2008
First Submitted That Met QC Criteria
April 15, 2008
First Posted (Estimate)
April 17, 2008
Study Record Updates
Last Update Posted (Estimate)
March 30, 2015
Last Update Submitted That Met QC Criteria
March 10, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1690C00004
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.
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