Treatment of GLP-1 for Diabetic Bariatric Patients (NOVO-GLP1)

GLP-1 Agonists as Neoadjuvant Therapy for Surgical Treatment of Type 2 Diabetes: A Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: Semaglutide (1 Mg Dose)

Detailed Description

The evidence to date supporting the association between treatment with GLP-1 agonists and diabetes remission after metabolic surgery is based on retrospective studies. This study is a 2:1 randomized, blinded, parallel, prospective placebo-controlled trial with a standardized treatment approach in order to establish the role of GLP-1 in remission of diabetes after metabolic surgery. This study will enroll 126 patients, with the goal of 100 patients completing the clinical trial (33 in the Placebo/Control Group and 67 in the Test Group).

The preoperative program for Metabolic Surgery involves multidisciplinary health evaluation and care, as well as patient education lasting approximately 6 months. Patients that consent to the clinical trial, will receive study drug on top of the standard care that is provided for 4 months prior to bariatric surgery. During this time, glycemic control will be monitored carefully through points of contact with the study team and additional lab assessments for the clinical trial. After bariatric surgery, patients will continue in the study for 2 years and glycemic control will be managed according to the current standard of care for perioperative glucose control. During this time, patients will continue to meet with the study team and collect lab assessments

All study patients will be followed for two years after metabolic surgery. Efficacy and outcomes will be evaluated by comparative analysis of laboratory results (Labs 1-6) which monitor longitudinal glycemic control. Outcomes will then be compared between Test and Control groups. The major study outcomes will be diabetes remission as defined by the American Diabetes Association. Secondary outcomes will include measures of improvement in glycemic control and beta cell function (change in fasting glucose levels, HbA1C, and C- peptide). All study labs and chemistry analysis will be performed at the Geisinger Medical Laboratory which is accredited by the College of American Pathologists and the Centers for Medicare and Medicaid - Clinical Laboratory Improvement Amendments (CLIA) and licensed by the Pennsylvania Department of Health Division of Laboratories. Evaluation of the continued need for medications for diabetes treatment will be the responsibility of the study team. Longitudinal information relating to medication use will be derived from direct patient contact at study visits, and review of standard of care medicine reconciliations from the Electronic Health Record.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Arm; Once weekly injection of placebo 4-6 months at prescribed dose	Drug: Placebo; Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery
Active Comparator: Test Arm; Once weekly injection of 1.0mg Semaglutide 4-6 months at prescribed dose	Drug: Semaglutide (1 Mg Dose); Weekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery; Other Names: semaglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RATE OF PARTIAL REMISSION OF DIABETES	HbA1C < 6.5%, fasting glucose <125 mg/dl, or no medications or active treatment for one year	11 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RATE OF COMPLETE REMISSION OF DIABETES	HbA1C < 6.0%, fasting glucose <100 mg/dl, or no medications or active treatment for o	11 months

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: Novo Nordisk A/S
• Investigators: Principal Investigator: Christopher Still, DO, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Semaglutide; Bariatric Surgery
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2020-0937; U1111-1242-4068 (Other Identifier: NOVO Nordisk)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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