Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

Summary

The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetes agents, or patients who are being treated with metformin, an SU, or a combination of metformin and an SU

Timeline

Start

2008-05-30

Primary completion

2019-04-18

Completion

2020-04-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Total Exenatide Twice Daily (EBID) vs Placebo; p = 0.444; LS Mean Difference -0.28 (95% CI -1.01 to 0.45); Mixed Models Analysis NCT00658021 ↗

Drugs

Indications