16-week Flexible vs. 8-week Semaglutide Titration

NCT ID: NCT04447859

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-23
• Study Completion Date: 2022-09-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

label recommended titration

Intervention Type: OTHER

label recommended titration

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)

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

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

Interventions

Semaglutide

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

Intervention Type: DRUG

label recommended titration

label recommended titration

Intervention Type: OTHER

Other Intervention Names

Ozempic

Eligibility Criteria

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):

• 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)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy Eldor, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

Tel-Aviv Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Roy Eldor, MD PhD

Role: CONTACT

roye@tlvmc.gov.il

+972-52-736-0680

Facility Contacts

Roy Eldor, MD PhD

Role: primary

roye@tlvmc.gov.il

+972-52-736-0680

Other Identifiers

0631-19

Identifier Type: -

Identifier Source: org_study_id