Study S000673

Randomized, Double-blind, Placebo-controlled, Dose Escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin and/or Basal Insulin

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT02803918
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: SINGLE
Status: COMPLETED
Enrollment: 23
Start: 2017-05-17
Primary completion: 2020-01-27
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Placebo; DRUG:Basal Insulin; DRUG:Metformin
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1176-6142

Registered primary outcomes

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]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0009184	A study on pharmacokinetics, pharmacodynamics and safety of lixisenatide in children and adolescents with type 2 diabetes. Barrientos-Pérez M, Pediatric diabetes	2022	Randomized trial	PMID 35411611 DOI	cites ClinicalTrials.gov:NCT02803918; registry reference DERIVED:35411611