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16-week Flexible vs. 8-week Semaglutide Titration | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

NCT04447859•Tel-Aviv Sourasky Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•1. The subject is a male.
•2. 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.
•3. 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):
+4 more criteria

Exclusion Criteria

•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.

Locations (1)

Tel-Aviv Medical Center

Tel Aviv, Israel

Key Dates

Start Date

February 23, 2020

Primary Completion Date

May 10, 2022

Completion Date

September 10, 2022

Last Updated

June 25, 2020

Enrollment

100

ESTIMATED participants

Conditions

Diabetes type2

Interventions

Semaglutide

DRUG

label recommended titration

OTHER

Contacts

Roy Eldor, MD PhD

CONTACT

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

Digital Individualized and Collaborative Treatment of T2D in General Practice Based on Decision Aid

NCT04880005

Diabetes type2

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RECRUITINGNA

Intermittent Fasting to Improve Insulin Secretion

NCT04607096

PreDiabetesDiabetes type2+2 more

View study

UNKNOWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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16-week Flexible vs. 8-week Semaglutide Titration

Inclusion Criteria

Exclusion Criteria

Digital Individualized and Collaborative Treatment of T2D in General Practice Based on Decision Aid

Intermittent Fasting to Improve Insulin Secretion

Organisational Models Supported by Technology for the Management of Diabetic Disease and Its Complications in a Diabetic Clinic Setting. A Randomised Controlled Trial Targeting Type 2 Diabetes Individuals With Non-ideal Glycemic Values