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
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
1 other identifier
interventional
311
6 countries
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes-mellitus
Started Oct 2011
Typical duration for phase_3 type-2-diabetes-mellitus
42 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
First Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
December 27, 2013
CompletedMarch 12, 2014
February 1, 2014
1.3 years
July 11, 2011
November 5, 2013
February 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adjusted Mean Change From Baseline in HbA1c Levels
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.
Baseline to week 24
Secondary Outcomes (4)
Adjusted Mean Change From Baseline in FPG
Baseline to week 24
Adjusted Mean Change From Baseline in Total Body Weight
Baseline to week 24
Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)
Baseline to week 24
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure
Baseline to week 8
Study Arms (2)
Dapagliflozin 10 mg tablet
EXPERIMENTALmatching placebo tablet
PLACEBO COMPARATORInterventions
10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- Men or women age ≥ 18 years old
- Stable dose combination of metformin and sulfonylurea
- HbA1c ≥7.7% and ≤11.0%
You may not qualify if:
- Type 1 diabetes mellitus or diabetes insipidus
- Recent cardiovascular events
- Kidney or urological disorders
- Hepatic disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (42)
Research Site
Edmonton, Alberta, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Halifax, Nova Scotia, Canada
Research Site
Sydney Mines, Nova Scotia, Canada
Research Site
Brampton, Ontario, Canada
Research Site
Etobicoke, Ontario, Canada
Research Site
Markham, Ontario, Canada
Research Site
Smiths Falls, Ontario, Canada
Research Site
Kensington, Prince Edward Island, Canada
Research Site
Laval, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Beroun, Czechia
Research Site
České Budějovice, Czechia
Research Site
Jílové u Prahy, Czechia
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Prague, Czechia
Research Site
Semily, Czechia
Research Site
Vyškov, Czechia
Research Site
Aßlar, Germany
Research Site
Berlin, Germany
Research Site
Dresden, Germany
Research Site
Falkensee, Germany
Research Site
Neuwied, Germany
Research Site
Pirna, Germany
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Kielce, Poland
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Lodz, Poland
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Lublin, Poland
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Poznan, Poland
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Warsaw, Poland
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Zgierz, Poland
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Banská Bystrica, Slovakia
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Košice, Slovakia
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Považská Bystrica, Slovakia
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Rimavská Sobota, Slovakia
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Barcelona, Catalonia, Spain
Research Site
Santa Coloma de Gramanet (bcn), Catalu?a, Spain
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A Coruña, Galicia, Spain
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Oviedo, Principality of Asturias, Spain
Research Site
A Coruña, Spain
Research Site
Barcelona, Spain
Research Site
Oviedo, Spain
Research Site
Santa Coloma de Gramenet (bcn), Spain
Related Publications (1)
Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S; Study 05 Group. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Diabetes Care. 2015 Mar;38(3):365-72. doi: 10.2337/dc14-0666. Epub 2015 Jan 15.
PMID: 25592197DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
For participants who did not complete 8 and/or 24 weeks, respectively, last observation carried forward (LOCF) was used for analyses of secondary endpoints. All endpoints were evaluated by excluding data after rescue.
Results Point of Contact
- Title
- Eva Johnsson
- Organization
- AstraZeneca
Study Officials
- 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
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
July 11, 2011
First Posted
July 12, 2011
Study Start
October 1, 2011
Primary Completion
January 1, 2013
Study Completion
August 1, 2013
Last Updated
March 12, 2014
Results First Posted
December 27, 2013
Record last verified: 2014-02