Study S000457

A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT01554618
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 84
Start: 2011-12-02
Primary completion: 2020-05-06
Lead sponsor: AstraZeneca
Conditions: Children and Adolescent With Type 2 Diabetes
Interventions: DRUG:Exenatide Once Weekly; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES

Registered primary outcomes

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) to Week 24 (Controlled Assessment Period) [Baseline (Week 0) and Week 24]
Percentage of Patients With On-Treatment Adverse Events (AEs) up to Week 24 (Controlled Assessment Period) [Day 1 (Week 0) up to Week 24, plus up to a maximum of 90 days follow up]
Percentage of Patients Positive for Anti-Drug Antibodies (ADAs) to Exenatide up to Week 24 [Samples were collected on Day 1 (Week 0), Week 4, Week 8, Week 12 and Week 24]

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
R0017380	Once-Weekly Exenatide in Youth With Type 2 Diabetes. Tamborlane WV, Diabetes care	2022	Randomized trial	PMID 35679098 DOI	cites ClinicalTrials.gov:NCT01554618; registry reference DERIVED:35679098