Treatment of GLP-1 for Diabetic Bariatric Patients

NCT04624672 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: 2020-0937U1111-1242-4068
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Bariatric Surgery; Semaglutide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• RATE OF COMPLETE REMISSION OF DIABETES

  11 months

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

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

Drug: Placebo

Test Arm

ACTIVE COMPARATOR

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

Drug: Semaglutide (1 Mg Dose)

Interventions

Semaglutide (1 Mg Dose) DRUG

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

Also known as: semaglutide

Test Arm

Placebo DRUG

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

Control Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Contraindications to semaglutide which include a personal or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia syndrome-2 (MEN-2)
• Previously randomized for participation in this trial.
• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
• Type 1 diabetes

Sponsors & Collaborators

• Geisinger Clinic: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Project Manager
• Organization: Geisinger Medical Center

kcunningham1@geisinger.edu

570-214-2245

Study Officials

• Christopher Still, DO

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Obesity Institute

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: August 25, 2021
• Primary Completion: July 18, 2022
• Study Completion: August 17, 2022
• Last Updated: November 14, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)