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Clinical Trial Details

Trial ID: L2336
Source ID: NCT00729326
Associated Drug: Exenatide
Title: Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00729326/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: exenatide|DRUG: sitagliptin|DRUG: placebo|DRUG: placebo
Outcome Measures: Primary: Change in Time-averaged Glucose During a 24 Hour Period, Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline)., baseline and 8 Weeks | Secondary: Change in Two-hour Postprandial Glucose After the Morning Meal, Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint), baseline and 8 Weeks|Change in Fasting Blood Glucose After the Morning Meal, Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint), baseline and 8 Weeks|Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal, Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint), baseline and 8 Weeks|Change in Postprandial Glucagon AUC Excursion After the Morning Meal, Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint), baseline and 8 Weeks|Change in Postprandial Triglyceride AUC After the Morning Meal, Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint), baseline and 8 Weeks|Change in Postprandial Triglyceride AUC Excursion After the Morning Meal, Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint), baseline and 8 Weeks|Change in Postprandial C-peptide AUC After the Morning Meal, Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint), baseline and 8 Weeks|Change in Postprandial C-peptide AUC Excursion After the Morning Meal, Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint), baseline and 8 Weeks|Change in Postprandial Insulin AUC After the Morning Meal, Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint), baseline and 8 Weeks|Change in Postprandial Insulin AUC Excursion After the Morning Meal, Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint), baseline and 8 Weeks|Change in Postprandial Active GLP-1 AUC After the Morning Meal, Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint), baseline and 8 Weeks|Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal, Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint), baseline and 8 Weeks|Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4), Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL, 4 Weeks|Episodes of Hypoglycemia (Baseline to Week 4), Number of episodes of hypoglycemia experienced during the first 4 weeks of the study, 4 weeks|Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8), Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL, 8 weeks|Episodes of Hypoglycemia (Week 4 to Week 8), Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study, 8 weeks|Percentage of Patients Experiencing Hypoglycemia (Overall), Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL, 4 weeks and 8 weeks|Episodes of Hypoglycemia (Overall), Number of episodes of hypoglycemia experienced overall during the study, 4 weeks and 8 weeks
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 83
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-08
Completion Date: 2009-10
Results First Posted: 2011-01-20
Last Update Posted: 2015-04-09
Locations: Research Site, San Antonio, Texas, United States
URL: https://clinicaltrials.gov/show/NCT00729326