16-week Flexible vs. 8-week Semaglutide Titration

Sponsor
Tel-Aviv Sourasky Medical Center
Study ID
NCT04447859
Phase
PHASE3
Status
Unknown

Conditions

  • Diabetes type2

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Slow semaglutide titration group vs. label recommended titration group (16-week flexible vs. 8-week semaglutide titration)
  • label recommended titration — OTHER
    label recommended titration

Study Details

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.

Key Dates

Start date
Feb 23, 2020
Status verified
Jun 2020
Primary completion
May 10, 2022
Completion
Sep 10, 2022

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: label recommended titration
    eight-week titration regimen as recommended in by the product label (0.25mg/week for 4 weeks, 0.5mg/week for 4 weeks, 1mg/week for the remainder of the therapy)
  • Experimental: Slow semaglutide titration
    A slower 16-week titration regimen (initiate treatment at 0.0675mg/week and increase the dose by 0.0675mg weekly until a dose of 1mg/week is reached)

Primary Outcome Measure

Gastrointestinal adverse events (GI-AEs) [ Time Frame: 16 weeks - from visit one to visit seven (and in each visit alone) ]

Central Contacts

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