Suspended

NOVO-GLP1GLP-1 Agonists for Diabetes Remission in Metabolic Surgery

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Study Aim

This study aims to evaluate the effectiveness of GLP-1 Agonists as a treatment for diabetes remission in individuals who have undergone metabolic surgery, with the primary outcome being the rate of partial diabetes remission, defined as having an HbA1C less than 6.5%, a fasting glucose less than 125 mg/dl, or no need for diabetes medications or active treatment for one year.

What is being tested

Semaglutide (1 Mg Dose)

+ Placebo

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 75 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: August 2021
See protocol details

Summary

Principal SponsorGeisinger Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 25, 2021

Actual date on which the first participant was enrolled.

This study is about exploring the role of GLP-1 agonists, a type of diabetes medication, in helping people with type 2 diabetes achieve remission after metabolic surgery. The goal is to enroll 126 patients, with the aim of having 100 patients complete the trial. The importance of this study lies in its potential to provide evidence for the effectiveness of GLP-1 agonists in diabetes remission after surgery, which is currently based on retrospective studies. Patients participating in this trial will receive the study drug in addition to standard care for 4 months prior to bariatric surgery. During this time, their blood sugar levels will be closely monitored through regular contact with the study team and additional lab tests. After surgery, patients will continue in the study for 2 years, with their blood sugar control managed according to current standards. The study's success will be measured by comparing changes in blood sugar control and diabetes remission rates between the group receiving the GLP-1 agonist and the control group. The primary outcome is the rate of partial remission of diabetes, defined as having an HbA1C less than 6.5%, a fasting glucose less than 125 mg/dl, or no need for diabetes medication or treatment for one year.

Official TitleGLP-1 Agonists as Neoadjuvant Therapy for Surgical Treatment of Type 2 Diabetes: A Randomized Controlled Trial
NCT04624672
Principal SponsorGeisinger Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

2 inclusion criteria required to participate
Candidates for Roux-en-Y Gastric Bypass Surgery with an established diagnosis of Type 2 diabetes requiring insulin treatment for glycemic control
Ability to provide informed consent before any trial-related activities
7 exclusion criteria prevent from participating
Contraindications to semaglutide which include a personal or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia syndrome-2 (MEN-2)
Prior metabolic surgery procedure
Use of GLP-1 analogues for diabetes treatment at the time of recruitment
Known or suspected allergy to semaglutide or the excipients in semaglutide, or related products.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Once weekly injection of 1.0mg Semaglutide 4-6 months at prescribed dose

Group II

Placebo
Once weekly injection of placebo 4-6 months at prescribed dose

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Geisinger Medical Center

Danville, United StatesOpen Geisinger Medical Center in Google Maps
SuspendedOne Study Center