Dapagliflozin DPPIV Inhibitor add-on Study
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin
1 other identifier
interventional
833
6 countries
88
Brief Summary
This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.
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 Oct 2009
Typical duration for phase_3 type-2-diabetes
88 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
September 23, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
October 14, 2013
CompletedJune 13, 2014
June 1, 2014
1.4 years
September 23, 2009
January 21, 2013
June 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adjusted Mean Change in HbA1c Levels
To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.
Baseline to Week 24
Secondary Outcomes (6)
Adjusted Mean Change in Body Weight
Baseline to Week 24
Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%
Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
Baseline to Week 24
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg
Baseline to Week 8
Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise
Baseline to Week 24
- +1 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORDapagliflozin 10 mg tablet
2
PLACEBO COMPARATORMatching placebo tablet
Interventions
Eligibility Criteria
You may qualify if:
- Patients with type 2 diabetes
- Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these
- Patients will be screened by a blood test and only those who need additional therapy can be enrolled
You may not qualify if:
- Patients with type 1 diabetes
- Patients with very poorly controlled diabetes
- Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (88)
Research Site
Huntsville, Alabama, United States
Research Site
Ozark, Alabama, United States
Research Site
Anaheim, California, United States
Research Site
Chula Vista, California, United States
Research Site
Greenbrae, California, United States
Research Site
Laguna Hills, California, United States
Research Site
Los Angeles, California, United States
Research Site
Riverside, California, United States
Research Site
West Hills, California, United States
Research Site
Boca Raton, Florida, United States
Research Site
DeLand, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Longwood, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Stone Mountain, Georgia, United States
Research Site
Wichita, Kansas, United States
Research Site
Lake Charles, Louisiana, United States
Research Site
Edina, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Pahrump, Nevada, United States
Research Site
Staten Island, New York, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Medord, Oregon, United States
Research Site
Lancaster, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Myrtle Beach, South Carolina, United States
Research Site
Simpsonville, South Carolina, United States
Research Site
Bristol, Tennessee, United States
Research Site
Corpus Christi, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
North Richland Hills, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Burke, Virginia, United States
Research Site
Manassas, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Lakewood, Washington, United States
Research Site
Berazategui, Buenos Aires, Argentina
Research Site
La Plata, Buenos Aires, Argentina
Research Site
Lanús, Buenos Aires, Argentina
Research Site
Mar del Plata, Buenos Aires, Argentina
Research Site
Morón, Buenos Aires, Argentina
Research Site
Buenos Aires, Buenos Aires F.D., Argentina
Research Site
Caba, Buenos Aires F.D., Argentina
Research Site
Córdoba, Córdoba Province, Argentina
Research Site
Salta, Salta Province, Argentina
Research Site
Santa Fe, Santa Fe Province, Argentina
Research Site
Bad Nauheim, Germany
Research Site
Berlin, Germany
Research Site
Dresden, Germany
Research Site
Hamburg, Germany
Research Site
Meissen, Germany
Research Site
Münster, Germany
Research Site
Pirna, Germany
Research Site
Wangen, Germany
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Mexico City, Mexico City, Mexico
Research Site
Ciechocinek, Poland
Research Site
Czechowice-Dziedzice, Poland
Research Site
Gdansk, Poland
Research Site
Gniewkowo, Poland
Research Site
Krakow, Poland
Research Site
Krotoszyn, Poland
Research Site
Mrągowo, Poland
Research Site
Poznan, Poland
Research Site
Sopot, Poland
Research Site
Torun, Poland
Research Site
Zabrze, Poland
Research Site
Łęczyca, Poland
Research Site
Bolton, Lancs, United Kingdom
Research Site
Burbage, Leicester, United Kingdom
Research Site
Sunbury-on-Thames, Middlesex, United Kingdom
Research Site
Wansford, Peterborough, United Kingdom
Research Site
Ecclesfield, Sheffield, United Kingdom
Research Site
Addlestone, Surrey, United Kingdom
Research Site
Bath, United Kingdom
Research Site
Belfast, United Kingdom
Research Site
Blackpool, United Kingdom
Research Site
Coventry, United Kingdom
Research Site
Harrow, United Kingdom
Related Publications (2)
Jabbour SA, Hardy E, Sugg J, Parikh S; Study 10 Group. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37(3):740-50. doi: 10.2337/dc13-0467. Epub 2013 Oct 21.
PMID: 24144654RESULTNatale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PMID: 38770818DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
For participants who did not complete 8 and/or 24 weeks, respectively, LOCF was used. All endpoints were evaluated by excluding data after rescue with the exception of systolic blood pressure which was evaluated regardless of rescue medication.
Results Point of Contact
- Title
- Eva Johnsson
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Serge Jabbour, MD
Thomas Jefferson University, Philadelphia
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
September 23, 2009
First Posted
September 25, 2009
Study Start
October 1, 2009
Primary Completion
March 1, 2011
Study Completion
September 1, 2011
Last Updated
June 13, 2014
Results First Posted
October 14, 2013
Record last verified: 2014-06