CKDkb: a knowledge base and platform for drug development against non-alcoholic fatty liver disease

Clinical Trial Details

Trial ID:	L7274
Source ID:	NCT01042977
Associated Drug:	Dapagliflozin
Title:	Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
Acronym:
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT01042977/results
Conditions:	Type 2 Diabetes Mellitus\|Cardiovascular Disease\|Inadequate Glycaemic Control
Interventions:	DRUG: Dapagliflozin\|DRUG: Placebo
Outcome Measures:	Primary: 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, 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 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: Adjusted Mean Percent Change in Body Weight, To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo., 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, To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum., Baseline to Week 24\|Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF), To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo., Baseline to Week 8\|Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF), To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo., Baseline to Week 24\|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg, To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8., Baseline to Week 8
Sponsor/Collaborators:	Sponsor: AstraZeneca \| Collaborators: Bristol-Myers Squibb
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	964
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date:	2010-03
Completion Date:	2012-12
Results First Posted:	2013-08-23
Last Update Posted:	2014-02-17
Locations:	Research Site, Birmingham, Alabama, United States\|Research Site, Scottsdale, Arizona, United States\|Research Site, Anaheim, California, United States\|Research Site, Bell Gardens, California, United States\|Research Site, Chino, California, United States\|Research Site, Chula Vista, California, United States\|Research Site, Huntington Beach, California, United States\|Research Site, Los Angeles, California, United States\|Research Site, Mission Hills, California, United States\|Research Site, Redondo Beach, California, United States\|Research Site, Riverside, California, United States\|Research Site, Sacramento, California, United States\|Research Site, San Diego, California, United States\|Research Site, Torrance, California, United States\|Research Site, Aventura, Florida, United States\|Research Site, Boca Raton, Florida, United States\|Research Site, Bradenton, Florida, United States\|Research Site, Brooksville, Florida, United States\|Research Site, Clearwater, Florida, United States\|Research Site, Dania, Florida, United States\|Research Site, Delray Beach, Florida, United States\|Research Site, New Smyrna Beach, Florida, United States\|Research Site, Orlando, Florida, United States\|Research Site, Springfield, Illinois, United States\|Research Site, Avon, Indiana, United States\|Research Site, Franklin, Indiana, United States\|Research Site, Greenfield, Indiana, United States\|Research Site, Muncie, Indiana, United States\|Research Site, Waterloo, Iowa, United States\|Research Site, Topeka, Kansas, United States\|Research Site, Paducah, Kentucky, United States\|Research Site, Alexandria, Louisiana, United States\|Research Site, Rockville, Maryland, United States\|Research Site, Kalamazoo, Michigan, United States\|Research Site, Livonia, Michigan, United States\|Research Site, Billings, Montana, United States\|Research Site, Berlin, New Jersey, United States\|Research Site, Brick, New Jersey, United States\|Research Site, Asheboro, North Carolina, United States\|Research Site, Fargo, North Dakota, United States\|Research Site, Cincinnati, Ohio, United States\|Research Site, Oklahoma City, Oklahoma, United States\|Research Site, Altoona, Pennsylvania, United States\|Research Site, Erie, Pennsylvania, United States\|Research Site, Holland, Pennsylvania, United States\|Research Site, Lancaster, Pennsylvania, United States\|Research Site, Media, Pennsylvania, United States\|Research Site, Philadelphia, Pennsylvania, United States\|Research Site, Austin, Texas, United States\|Research Site, Corpus Christi, Texas, United States\|Research Site, Dallas, Texas, United States\|Research Site, Irving, Texas, United States\|Research Site, Richardson, Texas, United States\|Research Site, San Antonio, Texas, United States\|Research Site, Sugarland, Texas, United States\|Research Site, Alexandria, Virginia, United States\|Research Site, Manassas, Virginia, United States\|Research Site, Buenos Aires, Caba, Argentina\|Research Site, Rosario, Santa Fe, Argentina\|Research Site, Cordoba, Argentina\|Research Site, Salta, Argentina\|Research Site, Santa Fe, Argentina\|Research Site, Blacktown, New South Wales, Australia\|Research Site, Broadmeadow, New South Wales, Australia\|Research Site, Hornsby, New South Wales, Australia\|Research Site, Wollongong, New South Wales, Australia\|Research Site, Carina Heights, Queensland, Australia\|Research Site, Kippa-ring, Queensland, Australia\|Research Site, Adelaide, South Australia, Australia\|Research Site, Bedford Park, South Australia, Australia\|Research Site, Keswick, South Australia, Australia\|Research Site, Box Hill, Victoria, Australia\|Research Site, Heidelberg, Victoria, Australia\|Research Site, Herston, Australia\|Research Site, Wien, Austria\|Research Site, Blagoevgrad, Bulgaria\|Research Site, Pernik, Bulgaria\|Research Site, Pleven, Bulgaria\|Research Site, Russe, Bulgaria\|Research Site, Sevlievo, Bulgaria\|Research Site, Sofia, Bulgaria\|Research Site, Stara Zagora, Bulgaria\|Research Site, Varna, Bulgaria\|Research Site, Calgary, Alberta, Canada\|Research Site, Edmonton, Alberta, Canada\|Research Site, Moncton, New Brunswick, Canada\|Research Site, Bay Roberts, Newfoundland and Labrador, Canada\|Research Site, Halifax, Nova Scotia, Canada\|Research Site, Etobicoke, Ontario, Canada\|Research Site, Ottawa, Ontario, Canada\|Research Site, Scarborough, Ontario, Canada\|Research Site, Thornhill, Ontario, Canada\|Research Site, Toronto, Ontario, Canada\|Research Site, Mirabel, Quebec, Canada\|Research Site, Quebec, Canada\|Research Site, Santiago, Region Metropolitana, Chile\|Research Site, Damme, Germany\|Research Site, Dortmund, Germany\|Research Site, Homburg, Germany\|Research Site, Munster, Germany\|Research Site, Wangen, Germany\|Research Site, Ajka, Hungary\|Research Site, Balatonfured, Hungary\|Research Site, Budapest, Hungary\|Research Site, Esztergom, Hungary\|Research Site, Gyor, Hungary\|Research Site, Komarom, Hungary\|Research Site, Mosonmagyarovar, Hungary\|Research Site, TAT, Hungary\|Research Site, Veszprem, Hungary\|Research Site, Bialystok, Poland\|Research Site, Chrzanow, Poland\|Research Site, Gdansk, Poland\|Research Site, Grodzisk Mazowiecki, Poland\|Research Site, Ilawa, Poland\|Research Site, Kielce, Poland\|Research Site, Krakow, Poland\|Research Site, Leczna, Poland\|Research Site, Leczyca, Poland\|Research Site, Lodz, Poland\|Research Site, Lublin, Poland\|Research Site, Mragowo, Poland\|Research Site, Nowy Sacz, Poland\|Research Site, Plock, Poland\|Research Site, Poznan, Poland\|Research Site, Ruda Slaska, Poland\|Research Site, Skierniewice, Poland\|Research Site, Sopot, Poland\|Research Site, Tarnow, Poland\|Research Site, Torun, Poland\|Research Site, Warszawa, Poland\|Research Site, Wroclaw, Poland\|Research Site, Zabrze, Poland\|Research Site, Zgierz, Poland\|Research Site, Zielona Gora, Poland
URL:	https://clinicaltrials.gov/show/NCT01042977

Knowledge Graph
Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress
D445	Dapagliflozin	small molecule	DB06292				Details

Clinical Trial Details

Summary

Knowledge Graph

Associated Data

Associated NAFLD Drugs (1)