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

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ClinicalTrials.gov Identifier: NCT04624672
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : September 16, 2021
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Christopher Still, Geisinger Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Semaglutide (1 Mg Dose) Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: GLP-1 Agonists as Neoadjuvant Therapy for Surgical Treatment of Type 2 Diabetes: A Randomized Controlled Trial
Actual Study Start Date : August 25, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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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 Name: semaglutide


Outcome Measures
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Primary Outcome Measures :
  1. RATE OF PARTIAL REMISSION OF DIABETES [ Time Frame: 1 year ]
    HbA1C < 6.5%, fasting glucose <125 mg/dl, or no medications or active treatment for one year


Secondary Outcome Measures :
  1. RATE OF COMPLETE REMISSION OF DIABETES [ Time Frame: 1 year ]
    HbA1C < 6.0%, fasting glucose <100 mg/dl, or no medications or active treatment for o


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04624672


Contacts
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Contact: Krystal Cunningham 570-214-2245 kcunningham1@geisinger.edu
Contact: Deanna Jarrett dljarrett@geisinger.edu

Locations
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United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Krystal Cunningham         
Sponsors and Collaborators
Geisinger Clinic
Novo Nordisk A/S
Investigators
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Principal Investigator: Christopher Still, DO Geisinger Clinic
More Information
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Responsible Party: Christopher Still, Director of Obesity Institute, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT04624672    
Other Study ID Numbers: 2020-0937
U1111-1242-4068 ( Other Identifier: NOVO Nordisk )
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Christopher Still, Geisinger Clinic:
Bariatric Surgery
Semaglutide
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases