Clinical Trial Details
| Trial ID: | L6769 |
| Source ID: | NCT00680745 |
| Associated Drug: | Dapagliflozin |
| Title: | Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00680745/results |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: dapagliflozin|DRUG: Glimepiride|DRUG: metformin hydrochloride|DRUG: pioglitazone hydrochloride|DRUG: Rosiglitazone |
| Outcome Measures: | Primary: Adjusted Mean Change in HbA1c Levels, To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period., Baseline to Week 24 | Secondary: Adjusted Mean Change in Body Weight, To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride., Baseline to Week 24|Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise, To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24., Baseline to Week 24|Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%, To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c \< 7% after 24 weeks of treatment, compared to placebo plus glimepiride., At Week 24|Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2, To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride., Baseline to Week 24|Adjusted Mean Change in Fasting Plasma Glucose (FPG), To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride., Baseline to Week 24 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 597 |
| 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: | 2010-05 |
| Results First Posted: | 2013-10-14 |
| Last Update Posted: | 2013-10-14 |
| Locations: | Research Site, Blansko, Czech Republic|Research Site, Breclav, Czech Republic|Research Site, Bruntal, Czech Republic|Research Site, Hodonin, Czech Republic|Research Site, Ostrava - Belsky Les, Czech Republic|Research Site, Plzen, Czech Republic|Research Site, Praha 1, Czech Republic|Research Site, Pribram Viii, Czech Republic|Research Site, Rakovnik, Czech Republic|Research Site, Semily, Czech Republic|Research Site, Balatonfured, Hungary|Research Site, Bekescsaba, Hungary|Research Site, Budapest, Hungary|Research Site, Csongrad, Hungary|Research Site, Eger, Hungary|Research Site, Gyongyos, Hungary|Research Site, Kecskemet, Hungary|Research Site, Mako, Hungary|Research Site, Miskolc, Hungary|Research Site, Mosonmagyarovar, Hungary|Research Site, Siofok, Hungary|Research Site, Szentes, Hungary|Research Site, TAT, Hungary|Research Site, Zalaegerszeg, Hungary|Research Site, Jeonju, Chonbuk, Korea, Republic of|Research Site, Wonju, Kangwon-do, Korea, Republic of|Research Site, Suwon, Kyunggi-do, Korea, Republic of|Research Site, Bucheon, Korea, Republic of|Research Site, Incheon, Korea, Republic of|Research Site, Seongnam, Korea, Republic of|Research Site, Seoul, Korea, Republic of|Research Site, Uljeongbu, Korea, Republic of|Research Site, Cebu City, Philippines|Research Site, Manila, Philippines|Research Site, Marikina City, Philippines|Research Site, Pasig City, Philippines|Research Site, Bielsko - Biala, Poland|Research Site, Bydgoszcz, Poland|Research Site, Chojnice, Poland|Research Site, Chrzanow, Poland|Research Site, Ciechocinek, Poland|Research Site, Czechowice-Dziedzice, Poland|Research Site, Elblag, Poland|Research Site, Gdansk, Poland|Research Site, Gniewkowo, Poland|Research Site, Grudziadz, Poland|Research Site, Ilawa, Poland|Research Site, Krakow, Poland|Research Site, Mragowo, Poland|Research Site, Plock, Poland|Research Site, Poznan, Poland|Research Site, Ruda Slaska, Poland|Research Site, Sopot, Poland|Research Site, Torun, Poland|Research Site, Wroclaw, Poland|Research Site, Zabrze, Poland|Research Site, Zielona Gora, Poland|Research Site, Zory, Poland|Research Site, Bangkok, Thailand|Research Site, Chiang Mai, Thailand|Research Site, Dnipropetrov'sk, Ukraine|Research Site, Donetsk, Ukraine|Research Site, Kharkiv, Ukraine|Research Site, Kiev, Ukraine|Research Site, Vinnytsia, Ukraine|Research Site, Zaporozhye, Ukraine |
| URL: | https://clinicaltrials.gov/show/NCT00680745 |
