Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who Exhibit Inadequate Glycaemic Control on Usual Care
1 other identifier
interventional
922
9 countries
140
Brief Summary
This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.
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-mellitus
Started Feb 2010
Longer than P75 for phase_3 type-2-diabetes-mellitus
140 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
December 10, 2009
CompletedFirst Posted
Study publicly available on registry
December 14, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
August 23, 2013
CompletedOctober 29, 2013
September 1, 2013
1.2 years
December 10, 2009
January 21, 2013
September 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adjusted Mean Change in HbA1c Levels
To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.
Baseline to Week 24
Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit
To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.
Baseline to week 24
Secondary Outcomes (4)
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)
Baseline to Week 8
Adjusted Mean Percent Change in Body Weight
Baseline to Week 24
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)
Baseline to Week 24
Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²
Baseline to Week 24
Study Arms (2)
1
EXPERIMENTALDapagliflozin 10 mg tablet
2
PLACEBO COMPARATORMatching placebo tablet
Interventions
Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus.
- Cardiovascular disease
- Hypertension
You may not qualify if:
- Patients with type 1 diabetes or diabetes insipidus
- Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
- Any clinically significant illness, which would compromise the patient's safety and their participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (140)
Research Site
Gulf Shores, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Burbank, California, United States
Research Site
Garden Grove, California, United States
Research Site
Huntington Park, California, United States
Research Site
Lancaster, California, United States
Research Site
Salinas, California, United States
Research Site
San Marino, California, United States
Research Site
San Ramon, California, United States
Research Site
Tustin, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Waterbury, Connecticut, United States
Research Site
Clearwater, Florida, United States
Research Site
Deerfield Beach, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Port Charlotte, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Columbus, Georgia, United States
Research Site
Decatur, Georgia, United States
Research Site
Stone Mountain, Georgia, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Chicago, Illinois, United States
Research Site
Wichita, Kansas, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Lake Charles, Louisiana, United States
Research Site
West Monroe, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Kansas City, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Brick, New Jersey, United States
Research Site
Oradell, New Jersey, United States
Research Site
New Hyde Park, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Phoenixville, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Reading, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Kingsport, Tennessee, United States
Research Site
Carrollton, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Fort Worth, Texas, United States
Research Site
Houston, Texas, United States
Research Site
North Richland Hills, Texas, United States
Research Site
Plano, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Tomball, Texas, United States
Research Site
Ogden, Utah, United States
Research Site
Danville, Virginia, United States
Research Site
Spokane, Washington, United States
Research Site
Tacoma, Washington, United States
Research Site
La Plata, 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
Mendoza, Mendoza Province, Argentina
Research Site
Santa Fe, Santa Fe Province, Argentina
Research Site
Buenos Aires, Argentina
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
Calgary, Alberta, Canada
Research Site
New Westminster, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Carbonear, Newfoundland and Labrador, Canada
Research Site
Mount Pearl, Newfoundland and Labrador, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Courtice, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Smiths Falls, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Lachine, Quebec, Canada
Research Site
Laval, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Saint-Marc-des-Carrieres, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Potsdam, BR, Germany
Research Site
Bad Nauheim, Germany
Research Site
Berlin, Germany
Research Site
Erdmannhausen, Germany
Research Site
Frankfurt, Germany
Research Site
Hamburg, Germany
Research Site
Heilbronn, Germany
Research Site
Hildesheim, Germany
Research Site
Mainz, Germany
Research Site
Münster, Germany
Research Site
Potsdam, Germany
Research Site
Speyer, Germany
Research Site
Wahlstedt, Germany
Research Site
Brasov, Brașov County, Romania
Research Site
Suceava, Suceava, Romania
Research Site
Brăila, Romania
Research Site
Bucharest, Romania
Research Site
Constanța, Romania
Research Site
Iași, Romania
Research Site
Sibiu, Romania
Research Site
Banská Bystrica, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Dolný Kubín, Slovakia
Research Site
Komárno, Slovakia
Research Site
Košice, Slovakia
Research Site
Kysucké Nové Mesto, Slovakia
Research Site
Liptovský Hrádok, Slovakia
Research Site
Lučenec, Slovakia
Research Site
Nitra, Slovakia
Research Site
Považská Bystrica, Slovakia
Research Site
Prievidza, Slovakia
Research Site
Rimavská Sobota, Slovakia
Research Site
Ružomberok, Slovakia
Research Site
Žilina, Slovakia
Research Site
Córdoba, Andalusia, Spain
Research Site
Granada, Andalusia, Spain
Research Site
Seville, Andalusia, Spain
Research Site
Palma de Mallorca, Balearic Islands, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Lleida, Catalonia, Spain
Research Site
Olot (girona), Catalonia, Spain
Research Site
A Coruña, Galicia, Spain
Research Site
Santiago de Compostela, Galicia, Spain
Research Site
Majadahonda, Madrid, Spain
Research Site
Oviedo, Principality of Asturias, Spain
Research Site
San Juan (alicante), Valencia, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Tainan County, Taiwan, Taiwan
Research Site
Changhua, Taiwan
Research Site
Kaohsiung City, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan District, Taiwan
Research Site
Hanoi, Vietnam, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Related Publications (2)
Natale 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: 38770818DERIVEDCefalu WT, Leiter LA, de Bruin TW, Gause-Nilsson I, Sugg J, Parikh SJ. Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a 28-Week Extension. Diabetes Care. 2015 Jul;38(7):1218-27. doi: 10.2337/dc14-0315. Epub 2015 Apr 7.
PMID: 25852208DERIVED
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. For HbA1c: excluding data after glycemic rescue, Weight: including data after rescue, SBP: excluding data after anti-hypertensive rescue.
Results Point of Contact
- Title
- Eva Johnsson
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. William Cefalu
Pennington Biomedical Research Center
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
December 10, 2009
First Posted
December 14, 2009
Study Start
February 1, 2010
Primary Completion
May 1, 2011
Study Completion
December 1, 2012
Last Updated
October 29, 2013
Results First Posted
August 23, 2013
Record last verified: 2013-09