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Clinical Trial Details

Trial ID: L4567
Source ID: NCT02803918
Associated Drug: Lixisenatide (Ave0010)
Title: A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Lixisenatide (AVE0010)|DRUG: Placebo|DRUG: Basal Insulin|DRUG: Metformin
Outcome Measures: Primary: Number of patients with adverse events (AEs), Up to 10 weeks|Number of patients with treatment-emergent adverse events (TEAEs), Up to 10 weeks|Number of patients with anti-lixisenatide antibodies, Up to 10 weeks | Secondary: Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration, Day 14, Day 28 and Day 42|Assessment of PK parameters: maximum concentration (Cmax), Day 42|Assessment of PK parameters: time to reach Cmax (Tmax), Day 42|Assessment of PK parameters: area under up to last concentration (AUClast), Day 42|Assessment of PK parameters: area under curve (AUC), Day 42|Assessment of pharmacodynamic parameter: plasma glucose AUC-0-4.5 hours, Day 14, Day 28 and Day 42
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: CHILD
Phases: PHASE1
Enrollment: 23
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2017-05-17
Completion Date: 2020-01-27
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 840002, Baton Rouge, Louisiana, 70808-4124, United States|Investigational Site Number 840006, New Orleans, Louisiana, 70115-6969, United States|Investigational Site Number 840009, Philadelphia, Pennsylvania, 19104, United States|Investigational Site Number 840007, Lufkin, Texas, 75904, United States|Investigational Site Number 480001, Phoenix, Mauritius|Investigational Site Number 484001, Monterrey, 64460, Mexico|Investigational Site Number 484002, Puebla, 72190, Mexico|Investigational Site Number 710001, Cape Town, 7530, South Africa|Investigational Site Number 724002, Barcelona, 08009, Spain|Investigational Site Number 792002, Ankara, 06500, Turkey|Investigational Site Number 792001, Izmir, 35100, Turkey
URL: https://clinicaltrials.gov/show/NCT02803918

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details