Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients
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.
1 other identifier
interventional
1,217
10 countries
76
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Mar 2008
Longer than P75 for phase_3 type-2-diabetes
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 15, 2008
CompletedFirst Posted
Study publicly available on registry
April 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
August 23, 2013
CompletedMarch 30, 2015
March 1, 2015
1.8 years
April 15, 2008
January 21, 2013
March 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adjusted Mean Change in HbA1c Levels
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.
Baseline to Week 52
Secondary Outcomes (3)
Adjusted Mean Change in Body Weight
Baseline to Week 52
Proportion of Participants With at Least One Episode of Hypoglycemia
Baseline to Week 52
Proportion of Participants With Body Weight Reduction of at Least 5%
Baseline to Week 52
Study Arms (2)
1
EXPERIMENTALdapagliflozin plus metformin
2
ACTIVE COMPARATORglipizide plus metformin
Interventions
Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- Type 1 Diabetes
- Insulin therapy within one year of enrolment
- Renal (kidney) failure or dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (76)
Research Site
Buenos Aires, Argentina
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Caba, Argentina
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Capital Federal, Argentina
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Ciudad de Buenos Aires, Argentina
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Corrientes, Argentina
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Córdoba, Argentina
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La Plata, Argentina
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Rosario, Argentina
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Santa Fe, Argentina
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L'Aigle, France
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Mûrs-Erigné, France
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Nantes, 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 im Harz, 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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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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The Hague, 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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eMkhomazi, 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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Witbank, South Africa
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Alicante, Spain
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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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Seville, Spain
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Gothenburg, Sweden
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Järfälla, Sweden
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Lund, Sweden
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Malmo, Sweden
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Skene, Sweden
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Södertälje, Sweden
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Stockholm, 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 Saint 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
Related Publications (2)
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.
PMID: 21816980RESULTNauck 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.
PMID: 23529570DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
For participants who did not complete 52 weeks LOCF (last observation carried forward) was used.
Results Point of Contact
- Title
- Eva Johnsson
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A. Nauck, Prof. Dr. med.
Diabeteszentrum Bad Lauterberg, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2008
First Posted
April 17, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2009
Study Completion
January 1, 2013
Last Updated
March 30, 2015
Results First Posted
August 23, 2013
Record last verified: 2015-03