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

Clinical Trial Details

Trial ID:	L2528
Source ID:	NCT01031680
Associated Drug:	Dapagliflozin
Title:	Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
Acronym:
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT01031680/results
Conditions:	Type 2 Diabetes Mellitus\|Cardiovascular Disease\|Hypertension\|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 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: Adjusted Mean Change in Seated Systolic Blood Pressure (SBP), 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 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\|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) 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\|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
Sponsor/Collaborators:	Sponsor: AstraZeneca \| Collaborators: Bristol-Myers Squibb
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	922
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date:	2010-02
Completion Date:	2012-12
Results First Posted:	2013-08-23
Last Update Posted:	2013-10-29
Locations:	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, Bronx, New York, United States\|Research Site, New Hyde Park, 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, Caba, Argentina\|Research Site, Buenos Aires, Argentina\|Research Site, Caba, Argentina\|Research Site, Ciudad de Buenos Aires, Argentina\|Research Site, Cordoba, Argentina\|Research Site, Mendoza, Argentina\|Research Site, Santa Fe, 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, Munster, Germany\|Research Site, Potsdam, Germany\|Research Site, Speyer, Germany\|Research Site, Wahlstedt, Germany\|Research Site, Braila, Romania\|Research Site, Brasov, Romania\|Research Site, Bucharest, Romania\|Research Site, Bucuresti, Romania\|Research Site, Constanta, Romania\|Research Site, Iasi, Romania\|Research Site, Sibiu, Romania\|Research Site, Suceava, Romania\|Research Site, Banska Bystrica, Slovakia\|Research Site, Bratislava, Slovakia\|Research Site, Dolny Kubin, Slovakia\|Research Site, Komarno, Slovakia\|Research Site, Kosice, Slovakia\|Research Site, Kysucke Nove Mesto, Slovakia\|Research Site, Liptovsky Hradok, Slovakia\|Research Site, Lucenec, Slovakia\|Research Site, Nitra, Slovakia\|Research Site, Povazska Bystrica, Slovakia\|Research Site, Prievidza, Slovakia\|Research Site, Rimavska Sobota, Slovakia\|Research Site, Ruzomberok, Slovakia\|Research Site, Zilina, Slovakia\|Research Site, Cordoba, Andalucia, Spain\|Research Site, Granada, Andalucia, Spain\|Research Site, Sevilla, Andalucia, Spain\|Research Site, Oviedo, Asturias, Spain\|Research Site, Barcelona, Cataluna, Spain\|Research Site, Lerida, Cataluna, Spain\|Research Site, Olot (girona), Cataluna, Spain\|Research Site, Majadahonda, Comunidad de Madrid, Spain\|Research Site, San Juan (alicante), Comunidad Valenciana, Spain\|Research Site, Valencia, Comunidad Valenciana, Spain\|Research Site, A Coruna, Galicia, Spain\|Research Site, Santiago de Compostela, Galicia, Spain\|Research Site, Palma de Mallorca, Islas Baleares, Spain\|Research Site, Changhua, Taiwan\|Research Site, Kaohsiung, Taiwan\|Research Site, Taichung, Taiwan\|Research Site, Tainan County, Taiwan\|Research Site, Taipei, Taiwan\|Research Site, Tao-yuan, Taiwan\|Research Site, Hanoi, Vietnam\|Research Site, Ho Chi Minh, Vietnam
URL:	https://clinicaltrials.gov/show/NCT01031680

Knowledge Graph
Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress
D445	Dapagliflozin	small molecule	DB06292				Details
D184	Simvastatin	small molecule	DB00641				Details

Clinical Trial Details

Summary

Knowledge Graph

Associated Data

Associated NAFLD Drugs (2)