Clinical trial NCT04447859: 16-week Flexible vs. 8-week Semaglutide Titration
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes type2
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Gastrointestinal adverse events (GI-AEs)
timeFrame: 16 weeks - from visit one to visit seven (and in each visit alone)
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel-Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Roy Eldor, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: