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

Clinical Trial Details

Trial ID:	L3582
Source ID:	NCT00984867
Associated Drug:	Dapagliflozin
Title:	Dapagliflozin DPPIV Inhibitor add-on Study
Acronym:
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT00984867/results
Conditions:	Type 2 Diabetes
Interventions:	DRUG: Dapagliflozin\|DRUG: Placebo
Outcome Measures:	Primary: 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: Adjusted Mean Change in Body Weight, To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24., Baseline to Week 24\|Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%, To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24., Baseline to Week 24\|Adjusted Mean Change in Fasting Plasma Glucose (FPG), To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24., Baseline to Week 24\|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg, To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP \>=130 achieved with dapagliflozin versus placebo from baseline to week 8., Baseline to Week 8\|Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise, To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24., Baseline to Week 24\|Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline, To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value., Baseline to Week 24
Sponsor/Collaborators:	Sponsor: AstraZeneca \| Collaborators: Bristol-Myers Squibb
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	833
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date:	2009-10
Completion Date:	2011-09
Results First Posted:	2013-10-14
Last Update Posted:	2014-06-13
Locations:	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, Mount 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, Lanus, Buenos Aires, Argentina\|Research Site, Mar Del Plata, Buenos Aires, Argentina\|Research Site, Moron, Buenos Aires, Argentina\|Research Site, Buenos Aires, Caba, Argentina\|Research Site, Caba, Argentina\|Research Site, Cordoba, Argentina\|Research Site, Salta, Argentina\|Research Site, Santa Fe, Argentina\|Research Site, Bad Nauheim, Germany\|Research Site, Berlin, Germany\|Research Site, Dresden, Germany\|Research Site, Hamburg, Germany\|Research Site, Meissen, Germany\|Research Site, Munster, Germany\|Research Site, Pirna, Germany\|Research Site, Wangen, Germany\|Research Site, Mexico, DF, Mexico\|Research Site, Guadalajara, Jalisco, 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, Leczyca, Poland\|Research Site, Mragowo, Poland\|Research Site, Poznan, Poland\|Research Site, Sopot, Poland\|Research Site, Torun, Poland\|Research Site, Zabrze, 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
URL:	https://clinicaltrials.gov/show/NCT00984867

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)