Clinical Trial Details
| Trial ID: | L6251 |
| Source ID: | NCT00641056 |
| Associated Drug: | Exenatide Once Weekly |
| Title: | Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00641056/results |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Exenatide Once Weekly|DRUG: Insulin Glargine |
| Outcome Measures: | Primary: Change in HbA1c From Baseline to Week 26, Change in HbA1c from baseline to Week 26, Baseline, Week 26 | Secondary: Percentage of Patients Achieving HbA1c <=7.0% at Week 26, Percentage of patients achieving HbA1c \<=7.0% at Week 26 (for patients with HbA1c \>7% at baseline), Baseline, Week 26|Percentage of Patients Achieving HbA1c <=6.5% at Week 26, Percentage of patients achieving HbA1c \<=6.5% at Week 26 (for patients with HbA1c \>6.5% at baseline), Baseline, Week 26|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26, Change in FSG (mmol/L) from Baseline to Week 26, Baseline, Week 26|Change in Body Weight (BW) From Baseline to Week 26, Change in BW (kg) from Baseline to Week 26, Baseline, Week 26|Change in Total Cholesterol From Baseline to Week 26, Change in Total Cholesterol (mmol/L) from Baseline to Week 26, Baseline, Week 26|Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26, Change in HDL (mmol/L) from Baseline to Week 26, Baseline, Week 26|Ratio of Triglycerides at Week 26 to Baseline, Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline., Baseline, Week 26|Change in Blood Pressure From Baseline to Week 26, Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26, Baseline, Week 26|Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes, Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia., Baseline to Week 26 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 467 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2008-04 |
| Completion Date: | 2009-11 |
| Results First Posted: | 2012-07-04 |
| Last Update Posted: | 2015-06-15 |
| Locations: | Research Site, Escondido, California, United States|Research Site, Jacksonville, Florida, United States|Research Site, Orlando, Florida, United States|Research Site, West Palm Beach, Florida, United States|Research Site, Honolulu, Hawaii, United States|Research Site, Idaho Falls, Idaho, United States|Research Site, Minneapolis, Minnesota, United States|Research Site, St. Louis, Missouri, United States|Research Site, Dayton, Ohio, United States|Research Site, Ada, Oklahoma, United States|Research Site, San Antonio, Texas, United States|Research Site, Spokane, Washington, United States|Research Site, Wollongong, New South Wales, Australia|Research Site, Herston, Queensland, Australia|Research Site, Adelaide, South Australia, Australia|Research Site, Keswick, South Australia, Australia|Research Site, Box Hill, Victoria, Australia|Research Site, Geelong, Victoria, Australia|Research Site, Brussels, Belgium|Research Site, Edegem, Belgium|Research Site, Melnik, Czech Republic|Research Site, Praha, Czech Republic|Research Site, Stodulky, Czech Republic|Research Site, Aalborg, Denmark|Research Site, Arhus C, Denmark|Research Site, Herlev, Denmark|Research Site, Koge, Denmark|Research Site, Angers, France|Research Site, Corbeil Essoness, France|Research Site, Nancy, France|Research Site, Nanterre, France|Research Site, Toulouse, France|Research Site, Bad Mergentheim, Germany|Research Site, Dresden, Germany|Research Site, Essen, Germany|Research Site, Falkensee, Germany|Research Site, Fulda, Germany|Research Site, Hamburg-Othmarschen, Germany|Research Site, Munster, Germany|Research Site, Rothenburg an der fulda, Germany|Research Site, Speyer, Germany|Research Site, Athens, Greece|Research Site, Thessaloniki, Greece|Research Site, Budapest, Hungary|Research Site, Eger, Hungary|Research Site, Gyula, Hungary|Research Site, Pecs, Hungary|Research Site, Gyeonggi-Do, Korea, Republic of|Research Site, Seoul, Korea, Republic of|Research Site, Merida, Mexico|Research Site, Mexico City, Mexico|Research Site, Tampico, Mexico|Research Site, Tijuana, Mexico|Research Site, Amsterdam, Netherlands|Research Site, Gouda, Netherlands|Research Site, Hoogeveen, Netherlands|Research Site, Rotterdam, Netherlands|Research Site, Zwijndrecht, Netherlands|Research Site, Zwolle, Netherlands|Research Site, Caguas, Puerto Rico|Research Site, Yabucoa, Puerto Rico|Research Site, Moscow, Russian Federation|Research Site, Rostov-on-Don, Russian Federation|Research Site, St. Petersburg, Russian Federation|Research Site, Alicante, Spain|Research Site, Alzira-Valencia, Spain|Research Site, Barcelona, Spain|Research Site, Bilbao, Spain|Research Site, Madrid, Spain|Research Site, Malaga, Spain|Research Site, Teruel, Spain|Research Site, Chia-Yi, Taiwan|Research Site, Tainan County, Taiwan|Research Site, Taipei, Taiwan|Research Site, Taoyuan, Taiwan |
| URL: | https://clinicaltrials.gov/show/NCT00641056 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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