Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

Phase 3 Completed 84 enrolled AstraZeneca

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study examines the Safety and efficacy study of exenatide once weekly in children and adolescents with type 2 diabetes

Timeline

Start: 2011-12-02
Primary completion: 2020-05-06
Completion: 2021-05-05

Outcome

Met primary endpoint

paper At 24 weeks, the least squares mean change in glycated hemoglobin was -0.36% for the exenatide and +0.49% for the placebo groups PMID 35679098 ↗

registry analysis (superiority test); Controlled Assessment Period - Placebo; p = 0.012; LS Mean Difference -0.85 (95% CI -1.51 to -0.19); Mixed Models Analysis NCT01554618 ↗

Publications

Tamborlane WV, Bishai R, Geller D, Shehadeh N, Al-Abdulrazzaq D, Vazquez EM, Karoly E, Troja T, Doehring O, Carter D, Monyak J, Sjostrom CD. Once-Weekly Exenatide in Youth With Type 2 Diabetes. Diabetes Care. 2022 Aug 1;45(8):1833-1840. doi: 10.2337/dc21-2275.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Exenatide	Peptide	2 mg	—

Indications

No indication recorded.