NCT04447859

16-week Flexible vs. 8-week Semaglutide Titration

A Randomized Controlled Open Label Pilot Study Examining the Safety of a 16 Week Flexible Titration Regimen vs. Label-recommended 8-week Semaglutide Titration Regimen

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes type2

Interventions

Type	Name	Description
DRUG	Semaglutide	Slow semaglutide titration group vs. label recommended titration group (16-week flexible vs. 8-week semaglutide titration)
OTHER	label recommended titration	label recommended titration

Timeline

• Start date: 2020-02-23
• Primary completion: 2022-05-10
• Completion: 2022-09-10
• First posted: 2020-06-25
• Last updated: 2020-06-25

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated drug study