Status:
UNKNOWN
16-week Flexible vs. 8-week Semaglutide Titration
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Diabetes type2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 administer...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
February 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04447859
Start Date
February 23 2020
End Date
September 10 2022
Last Update
June 25 2020
Active Locations (1)
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1
Tel-Aviv Medical Center
Tel Aviv, Israel