16-week Flexible vs. 8-week Semaglutide Titration

NCT04447859 | Unknown Phase 3 FDA Drug

• 1 other identifier: 0631-19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal adverse events (GI-AEs)

  % occurrence of GI-AEs over time (pooled nausea, vomiting, diarrhea and every component alone)

  16 weeks - from visit one to visit seven (and in each visit alone)

Study Arms (2)

label recommended titration

ACTIVE COMPARATOR

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)

Other: label recommended titration

Slow semaglutide titration

EXPERIMENTAL

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)

Drug: Semaglutide

Interventions

Semaglutide DRUG

Slow semaglutide titration group vs. label recommended titration group (16-week flexible vs. 8-week semaglutide titration)

Also known as: Ozempic

Slow semaglutide titration

label recommended titration OTHER

label recommended titration

label recommended titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have personally signed and dated the informed consent form indicating that he/she has been informed of all pertinent aspects of the trial.
• Be willing and able to comply with the scheduled visits and other study procedures.
• Meet one of the following categories:
• The subject is a male.
• The subject is a female who is not of reproductive potential, defined as a female who either: (1) is postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing.
• The subject is a female who is of reproductive potential and agrees to avoid becoming pregnant: while receiving study drug and for 60 days after the last dose of study drug by complying with one of the following: (1) practice abstinence† from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity. Acceptable methods of contraception are‡:
• Single method (one of the following is acceptable):
• non-hormonal intrauterine device (IUD)
• vasectomy of a female subject's male partner
• Combination method (requires use of two of the following):
• diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)
• cervical cap with spermicide (nulliparous women only)
• contraceptive sponge (nulliparous women only)
• male condom or female condom (cannot be used together)

You may not qualify if:

• Has a known contraindication to use of GLP-1 agonists.
• Has been treated with a GLP-1 agonist in the last 30 days.
• Has a history of type 1 diabetes mellitus
• Has a medical history of untreated active proliferative retinopathy.
• Has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or blinded investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Interventions

semaglutide

Study Officials

• Roy Eldor, MD PhD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roy Eldor, MD PhD

CONTACT

+972-52-736-0680; roye@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 25, 2020
• Study Start: February 23, 2020
• Primary Completion: May 10, 2022
• Study Completion: September 10, 2022
• Last Updated: June 25, 2020

Record last verified: 2020-06

Locations

IL (1)