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Clinical Trial Details

Trial ID: L2163
Source ID: NCT02168491
Associated Drug: Lixisenatide
Title: Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin
Acronym: LixiBIT
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02168491/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Lixisenatide|DRUG: Insulin glargine
Outcome Measures: Primary: Change in HbA1c From Baseline to End, A change between two time points is reported. Time Frame: baseline and 12 weeks., 12 weeks | Secondary: Change in Fasting Plasma Glucose (FPG, Mean Over 2 Weeks), Patients will be instructed to record all insulin injections and a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) during a one-week prestudy run-in period to confirm compliance and document current metabolic control and doses of premixed insulin. Patients will be asked to record not only glucose profiles (at least 4 measurements per day) but also the occurrence of hypoglycemic symptoms or other adverse effects daily throughout the study. During the last week of the study patients will be asked to again record a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) and drug injections to confirm compliance and document metabolic control., 12 weeks|Change in Body Weight From Baseline to End of Study, A change between two time points is reported. Time Frame: baseline and 12 weeks., 12 weeks
Sponsor/Collaborators: Sponsor: Medical University of Vienna
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-11
Completion Date: 2015-08
Results First Posted: 2017-04-04
Last Update Posted: 2017-05-09
Locations: Medical University Of Vienna, Department of Internal Medicine III, Vienna, 1090, Austria
URL: https://clinicaltrials.gov/show/NCT02168491