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

Clinical Trial Details

Trial ID:	L2059
Source ID:	NCT00673231
Associated Drug:	Dapagliflozin
Title:	Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin
Acronym:
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT00673231/results
Conditions:	Type 2 Diabetes
Interventions:	DRUG: Dapagliflozin\|DRUG: Dapagliflozin\|DRUG: Dapagliflozin\|DRUG: Placebo\|DRUG: Dapagliflozin\|DRUG: Dapagliflozin
Outcome Measures:	Primary: Adjusted Mean Change in HbA1c Levels, To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration., Baseline to Week 24 \| Secondary: Adjusted Mean Change in Body Weight, To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration., Baseline to Week 24\|Adjusted Mean Change in Calculated Mean Daily Insulin Dose, To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration., Baseline to Week 24\|Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction, To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction \>= 10%) as compared to placebo added to insulin treatment., Baseline to Week 24\|Adjusted Mean Change in Fasting Plasma Glucose (FPG), To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration., Baseline to Week 24 \| Other: Proportion of Participants With Lack of Glycemic Control, Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets, Baseline to Week 24
Sponsor/Collaborators:	Sponsor: AstraZeneca \| Collaborators: Bristol-Myers Squibb
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	1240
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date:	2008-04
Completion Date:	2011-01
Results First Posted:	2013-08-23
Last Update Posted:	2013-10-29
Locations:	Research Site, Fresno, California, United States\|Research Site, Greenbrae, California, United States\|Research Site, Roswell, Georgia, United States\|Research Site, Chicago, Illinois, United States\|Research Site, Springfield, Illinois, United States\|Research Site, Indianapolis, Indiana, United States\|Research Site, Omaha, Nebraska, United States\|Research Site, Philadelphia, Pennsylvania, United States\|Research Site, Corpus Christi, Texas, United States\|Research Site, Dallas, Texas, United States\|Research Site, Norfolk, Virginia, United States\|Research Site, Richmond, Virginia, United States\|Research Site, Tacoma, Washington, United States\|Research Site, Salzburg, Austria\|Research Site, Wien, Austria\|Research Site, Pleven, Bulgaria\|Research Site, Russe, Bulgaria\|Research Site, Sofia, Bulgaria\|Research Site, Varna, Bulgaria\|Research Site, Calgary, Alberta, Canada\|Research Site, Kelowna, British Columbia, Canada\|Research Site, Langley, British Columbia, Canada\|Research Site, Winnipeg, Manitoba, Canada\|Research Site, Moncton, New Brunswick, Canada\|Research Site, Mount Pearl, Newfoundland and Labrador, Canada\|Research Site, St. John's, Newfoundland and Labrador, Canada\|Research Site, Halifax, Nova Scotia, Canada\|Research Site, Etobicoke, Ontario, Canada\|Research Site, Kingston, Ontario, Canada\|Research Site, London, Ontario, Canada\|Research Site, Oakville, Ontario, Canada\|Research Site, Scarborough, Ontario, Canada\|Research Site, Thornhill, Ontario, Canada\|Research Site, Chicoutimi, Quebec, Canada\|Research Site, Longueuil, Quebec, Canada\|Research Site, Mirabel, Quebec, Canada\|Research Site, Sherbrooke, Quebec, Canada\|Research Site, Helsinki, Finland\|Research Site, Joensuu, Finland\|Research Site, Jyvaskyla, Finland\|Research Site, Kuopio, Finland\|Research Site, Lahti, Finland\|Research Site, Oulu, Finland\|Research Site, Seinajoki, Finland\|Research Site, Turku, Finland\|Research Site, Bad Oeynhausen, Germany\|Research Site, Dortmund, Germany\|Research Site, Dresden, Germany\|Research Site, Essen, Germany\|Research Site, Frankfurt, Germany\|Research Site, Magdeburg, Germany\|Research Site, Münster, Germany\|Research Site, Riesa, Germany\|Research Site, Wolmirstedt, Germany\|Research Site, Csongrad, Hungary\|Research Site, Esztergom, Hungary\|Research Site, Gyor, Hungary\|Research Site, Kaposvar, Hungary\|Research Site, Kecskemet, Hungary\|Research Site, Komarom, Hungary\|Research Site, Miskolc, Hungary\|Research Site, Szekesfehervar, Hungary\|Research Site, Veszprem, Hungary\|Research Site, Amersfoort, Netherlands\|Research Site, Den Helder, Netherlands\|Research Site, Leiden, Netherlands\|Research Site, Rotterdam, Netherlands\|Research Site, Tg Mures, Mures, Romania\|Research Site, Brasov, Romania\|Research Site, Bucuresti, Romania\|Research Site, Moscow, Russian Federation\|Research Site, Nizhnii Novgorod, Russian Federation\|Research Site, Saint- Petersburg, Russian Federation\|Research Site, St Petersburg, Russian Federation\|Research Site, St. Petersburg, Russian Federation\|Research Site, St.-petersburg, Russian Federation\|Research Site, St.petersburg, Russian Federation\|Research Site, Bratislava, Slovakia\|Research Site, Dolny Kubin, Slovakia\|Research Site, Kosice, Slovakia\|Research Site, Levice, Slovakia\|Research Site, Lucenec, Slovakia\|Research Site, Povazska Bystrica, Slovakia\|Research Site, Presov, Slovakia\|Research Site, Sevilla, Andalucia, Spain\|Research Site, Sabadell (barcelona), Cataluna, Spain\|Research Site, Madrid, Comunidad de Madrid, Spain\|Research Site, Alicante, Comunidad Valenciana, Spain\|Research Site, Reading, Berks, United Kingdom\|Research Site, Aylesbury, Bucks, United Kingdom\|Research Site, Ashford, United Kingdom\|Research Site, Birmingham, United Kingdom\|Research Site, Cardiff, United Kingdom\|Research Site, Liverpool, United Kingdom\|Research Site, Reading, United Kingdom\|Research Site, Swansea, United Kingdom
URL:	https://clinicaltrials.gov/show/NCT00673231

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

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Associated Data

Associated NAFLD Drugs (1)