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Clinical Trial Details

Trial ID: L3003
Source ID: NCT01029886
Associated Drug: Exenatide Once Weekly
Title: Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01029886/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: exenatide once weekly|DRUG: liraglutide
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 26, Change in HbA1c from baseline to the treatment endpoint at Week 26., Baseline, Week 26 | Secondary: Percentage of Patients Achieving HbA1c <7.0% at Week 26, Percentage of patients achieving HbA1c \<7.0% at treatment endpoint at Week 26., Baseline, Week 26|Change in Fasting Serum Glucose From Baseline to Week 26, Change in fasting serum glucose from baseline to the treatment endpoint at Week 26., Baseline, Week 26|Change in Body Weight From Baseline to Week 26, Change in body weight from baseline to the treatment endpoint at Week 26., Baseline, Week 26|Change in Total Cholesterol From Baseline to Week 26, Change in total cholesterol from baseline to the treatment endpoint at Week 26., Baseline, Week 26|Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26, Change in HDL-C from baseline to the treatment endpoint at Week 26., Baseline, Week 26|Ratio of Fasting Triglycerides at Week 26 to Baseline, Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline., Baseline, Week 26|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26, Change in SBP from baseline to the treatment endpoint at Week 26., Baseline, Week 26|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26, Change in DBP from baseline to the treatment endpoint at Week 26., Baseline, Week 26|Assessment of Event Rate of Treatment-emergent Hypoglycemic Events, 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 sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT., Baseline to Week 26
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 912
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-01
Completion Date: 2011-04
Results First Posted: 2012-03-21
Last Update Posted: 2015-04-09
Locations: Research Site, Buenos Aires, Argentina|Research site, Mendoza, Argentina|Research Site, Rosario, Argentina|Research Site, Box Hill, Australia|Research Site, Geelong, Australia|Research Site, Keswick, Australia|Research Site, Vienna, Austria|Research site, Bonheiden, Belgium|Research Site, Edegem, Belgium|Research Site, Genk, Belgium|Research Site, Leuven, Belgium|Research Site, Liege, Belgium|Research Site, Charlottetown, Canada|Research Site, Gatineau, Canada|Research Site, Ottawa, Canada|Research Site, Sherbrooke, Canada|Research Site, Vancouver, Canada|Research Site, Victoria, Canada|Research Site, Windsor, Canada|Research Site, Winnipeg, Canada|Research Site, Brandys nad Labem, Czech Republic|Research Site, Prague 2, Czech Republic|Research Site, Prerov, Czech Republic|Research Site, Grenoble, France|Research Site, Le Creuzot, France|Research Site, Marseille Cedex 5, France|Research Site, Marseille Cedex 9, France|Research Site, Marseille, France|Research Site, Paris, France|Research Site, Poitiers, France|Research Site, Reims Cedex, France|Research Site, Strasbourg, France|Research Site, Bad Staffelstein, Germany|Research Site, Beckum, Germany|Research Site, Biberach, Germany|Research Site, Datteln, Germany|Research Site, Dresden, Germany|Research Site, Essen, Germany|Research Site, Ludwigshafen, Germany|Research Site, Mainz, Germany|Research Site, Meissen, Germany|Research Site, Muenster, Germany|Research Site, Regensburg, Germany|Research Site, Riesa, Germany|Research Site, Stuttgart, Germany|Research Site, Athens, Greece|Research Site, Cholargos, Greece|Research Site, Patras, Greece|Research Site, Bekescsaba, Hungary|Research Site, Budapest, Hungary|Research Site, Mako, Hungary|Research Site, Mosonmagyarovar, Hungary|Research Site, Nagykanizsa, Hungary|Research Site, Szekesfehervar, Hungary|Research Site, Aligarh, India|Research Site, Bangalore, India|Research Site, Chennai, India|Research Site, Coimbatore, India|Research Site, Hyderabad, India|Research Site, Indore, India|Research Site, Karnal/Haryana, India|Research site, Karnataka, India|Research Site, Mumbai, India|Research Site, Pune, India|Research Site, Beer Sheva, Israel|Research Site, Haifa, Israel|Research Site, Jerusalem, Israel|Research Site, Raanana, Israel|Research Site, Bari, Italy|Research Site, Cagliari, Italy|Research Site, Catanzaro, Italy|Research Site, Chieti, Italy|Research Site, Napoli, Italy|Research Site, Roma, Italy|Research Site, Treviglio, Italy|Research Site, Seoul, Korea, Republic of|Research Site, Ulsan, Korea, Republic of|Research Site, Guadalajara, Mexico|Research Site, Mexico, Mexico|Research Site, Monterrey, Mexico|Research Site, Bialystok, Poland|Research Site, Krakow, Poland|Research Site, Lodz, Poland|Research Site, Poznan, Poland|Research site, Rzeszow, Poland|Research Site, Warszawa, Poland|Research site, Bucuresti, Romania|Research site, Galati, Romania|Research site, Iasi, Romania|Research site, Oradea, Romania|Research Site, Bratislava, Slovakia|Research Site, Kosice, Slovakia|Research Site, Malacky, Slovakia|Research Site, Martin, Slovakia|Research Site, Halfway House, South Africa|Research Site, Johannesburg, South Africa|Research Site, Kempton Park, South Africa|Research Site, Parktown, South Africa|Research Site, Pretoria, South Africa|Research Site, Alcira, Spain|Research Site, Alicante, Spain|Research Site, Bilbao, Spain|Research Site, Madrid, Spain|Research Site, Majadahonda, Spain|Research Site, Teruel, Spain|Research Site, Changhua, Taiwan|Research Site, Jhonghe, Taiwan|Research Site, Sindian, Taiwan|Research Site, Taichung, Taiwan|Research Site, Yung-Kang, Tainan, Taiwan
URL: https://clinicaltrials.gov/show/NCT01029886

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