Back to results16-week Flexible vs. 8-week Semaglutide Titration
Primary Purpose
Diabetes type2
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Semaglutide
label recommended titration
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes type2
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:
- 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 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.
Sites / Locations
- Tel-Aviv Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
label recommended titration
Slow semaglutide titration
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Gastrointestinal adverse events (GI-AEs)
% occurrence of GI-AEs over time (pooled nausea, vomiting, diarrhea and every component alone)
Secondary Outcome Measures
Full Information
NCT ID
NCT04447859
First Posted
June 17, 2020
Last Updated
June 24, 2020
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04447859
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 23, 2020 (Actual)
Primary Completion Date
May 10, 2022 (Anticipated)
Study Completion Date
September 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes type2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
label recommended titration
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Slow semaglutide titration
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Other Intervention Name(s)
Ozempic
Intervention Description
Slow semaglutide titration group vs. label recommended titration group (16-week flexible vs. 8-week semaglutide titration)
Intervention Type
Other
Intervention Name(s)
label recommended titration
Intervention Description
label recommended titration
Primary Outcome Measure Information:
Title
Gastrointestinal adverse events (GI-AEs)
Description
% occurrence of GI-AEs over time (pooled nausea, vomiting, diarrhea and every component alone)
Time Frame
16 weeks - from visit one to visit seven (and in each visit alone)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roy Eldor, MD PhD
Phone
+972-52-736-0680
Email
roye@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Eldor, MD PhD
Organizational Affiliation
Tel Aviv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roy Eldor, MD PhD
Phone
+972-52-736-0680
Email
roye@tlvmc.gov.il
12. IPD Sharing Statement
Learn more about this trial
16-week Flexible vs. 8-week Semaglutide Titration
We'll reach out to this number within 24 hrs