Treatment of GLP-1 for Diabetic Bariatric Patients

NCT ID: NCT04624672

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-25
• Study Completion Date: 2022-08-17

Brief Summary

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.

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Arm

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery

Test Arm

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

Group Type: ACTIVE_COMPARATOR

Semaglutide (1 Mg Dose)

Intervention Type: DRUG

Weekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery

Interventions

Semaglutide (1 Mg Dose)

Weekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery

Intervention Type: DRUG

Placebo

Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery

Intervention Type: DRUG

Other Intervention Names

semaglutide

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Christopher Still

Director of Obesity Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Still, DO

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Medical Center

Danville, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U1111-1242-4068

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0937

Identifier Type: -

Identifier Source: org_study_id