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Clinical Trial Details

Trial ID: L3239
Source ID: NCT00324363
Associated Drug: Exenatide
Title: Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: exenatide|DRUG: Placebo
Outcome Measures: Primary: To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas., 16 weeks | Secondary: To compare exenatide and placebo groups with respect to: *safety and tolerability; *proportion of patients achieving HbA1c<=7%; *body weight; *incidence and rate of hypoglycemic events; *glucose measurements, 16 weeks
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 466
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-01
Completion Date: 2007-04
Results First Posted:
Last Update Posted: 2015-02-23
Locations: Research Site, Beijing, China|Research Site, Guangzhou, China|Research Site, Nanjing, China|Research Site, Shanghai, China|Research Site, Sichuan, China|Research Site, Chennai, India|Research Site, Mumbai, India|Research Site, Pune, India|Research Site, Seoul, Korea, Republic of|Research Site, Sungnam City, Korea, Republic of|Research Site, Chiayi, Taiwan|Research Site, Taichung, Taiwan|Research Site, Tainan, Taiwan|Research Site, Taipei, Taiwan
URL: https://clinicaltrials.gov/show/NCT00324363