Clinical Trial Details
| Trial ID: | L2585 |
| Source ID: | NCT01217892 |
| Associated Drug: | Dapagliflozin |
| Title: | Evaluation of Dapagliflozin Taken Twice-daily |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01217892/results |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: dapagliflozin|DRUG: dapagliflozin|DRUG: dapagliflozin|DRUG: metformin|DRUG: placebo |
| Outcome Measures: | Primary: Adjusted Mean Change in HbA1c Levels, To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment., Baseline to Week 16 | Secondary: Adjusted Percent Change in Body Weight, To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment., Baseline to Week 16|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1, To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment., Baseline to Week 1|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16, To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment., Baseline to Week 16|Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline., To compare the adjusted proportions controlling for baseline HbA1c \[acc. to Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu\] of participants with HbA1c \<7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline., Baseline to Week 16 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 400 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2010-11 |
| Completion Date: | 2011-08 |
| Results First Posted: | 2013-11-01 |
| Last Update Posted: | 2014-10-27 |
| Locations: | Research Site, Asslar, Germany|Research Site, Berlin, Germany|Research Site, Biberach A.d. Riss, Germany|Research Site, Bosenheim, Germany|Research Site, Dippoldiswalde, Germany|Research Site, Falkensee, Germany|Research Site, Meissen, Germany|Research Site, Munchen, Germany|Research Site, Neuwied, Germany|Research Site, Pirna, Germany|Research Site, Wahlstedt, Germany|Research Site, Balatonfured, Hungary|Research Site, Budapest, Hungary|Research Site, Csongrad, Hungary|Research Site, Debrecen, Hungary|Research Site, Gyongyos, Hungary|Research Site, Kecskemet, Hungary|Research Site, Mako, Hungary|Research Site, Nyiregyhaza, Hungary|Research Site, TAT, Hungary|Research Site, Zalaegerszeg, Hungary|Research Site, Brasov, Romania|Research Site, Bucuresti, 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, Kosice, Slovakia|Research Site, Lucenec, Slovakia|Research Site, Namestovo, Slovakia|Research Site, Piestany, Slovakia|Research Site, Prievidza, Slovakia|Research Site, Rimavska Sobota, Slovakia|Research Site, Ruzomberok, Slovakia|Research Site, Zilina, Slovakia|Research Site, Verulam, Kwa Zulu Natal, South Africa|Research Site, Cape Town, South Africa|Research Site, Durban, South Africa|Research Site, Johannesburg, South Africa|Research Site, Umkomaas, South Africa|Research Site, Chur, Graubunden, Switzerland|Research Site, Basel, Switzerland|Research Site, Bern, Switzerland|Research Site, Geneva 14, Switzerland|Research Site, Kreuzlingen, Switzerland|Research Site, Lugano, Switzerland|Research Site, Rorschach, Switzerland|Research Site, Dnipropetrov'sk, Ukraine|Research Site, Kiev, Ukraine|Research Site, Vinnytsia, Ukraine|Research Site, Vynnitsa, Ukraine|Research Site, Zaporozhye, Ukraine |
| URL: | https://clinicaltrials.gov/show/NCT01217892 |
