NOVO-GLP1 trial results
GLP-1 Agonists as Neoadjuvant Therapy for Surgical Treatment of Type 2 Diabetes: A Randomized Controlled Trial
- Participants
- 3
- Status
- terminated
- Completed
- 2022-08-17
- Sponsor
- Geisinger Clinic
As posted on ClinicalTrials.gov (NCT04624672), updated at source Nov 14, 2023. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
How NOVO-GLP1 was run
This study is for patients that are diabetic, and require insulin for glycemic control, and going through the bariatric surgery process. This is a prospective study that is trying to determine if the introduction of a semaglutide increases the remission rates of diabetes post-operatively.
- Control Arm: Once weekly injection of placebo 4-6 months at prescribed dose
- Test Arm: Once weekly injection of 1.0mg Semaglutide 4-6 months at prescribed dose
Who could join the trial
Inclusion Criteria: 1. Candidates for Roux-en-Y Gastric Bypass Surgery with an established diagnosis of Type 2 diabetes requiring insulin treatment for glycemic control 2. Ability to provide informed consent before any trial-related activities Exclusion Criteria: 1. Prior metabolic surgery procedure 2. Use of GLP-1 analogues for diabetes treatment at the time of recruitment 3. Known or suspected allergy to semaglutide or the excipients in semaglutide, or related products. 4. Contraindications to semaglutide which include a personal or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia syndrome-2 (MEN-2) 5. Previously randomized for participation in this trial. 6. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures. 7. Type 1 diabetes
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.