drugset / Trial / NCT04447859

16-week Flexible vs. 8-week Semaglutide Titration

NCT04447859

Phase 3 Unknown 100 enrolled Tel-Aviv Sourasky Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Semaglutide is a Glucagon Like Peptide 1 (GLP-1) receptor agonist recently approved in Israel to improve glycemic control in patients with type 2 diabetes mellitus. Semaglutide is currently administered as a weekly subcutaneous injection.Treatment with semaglutide is associated with the occurrence of gastrointestinal adverse events (GI-AEs) commonly observed during GLP-1 receptor agonist treatment. The most common adverse reactions, reported in ≥5% of patients treated with semaglutide are nausea, vomiting, diarrhea, abdominal pain and constipation. In this trial we plan to explore the effect of a slower titration regimen of semaglutide vs. the current label-recommended dose escalation regimen on the occurrence of GI-AEs.

Timeline

Start
2020-02-23
Primary completion
2022-05-10
Completion
2022-09-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Semaglutide Peptide 1 mg Subcutaneous