Diabetes Mellitus, Type 2
Conditions
Keywords
Bariatric Surgery, Semaglutide
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.
Interventions
Weekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery
DRUGPlacebo
Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery
Sponsors
Novo Nordisk A/S
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RATE OF PARTIAL REMISSION OF DIABETES | 11 months | HbA1C \< 6.5%, fasting glucose \<125 mg/dl, or no medications or active treatment for one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RATE OF COMPLETE REMISSION OF DIABETES | 11 months | HbA1C \< 6.0%, fasting glucose \<100 mg/dl, or no medications or active treatment for o |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Arm Once weekly injection of placebo 4-6 months at prescribed dose
Placebo: Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery | 0 |
| Test Arm Once weekly injection of 1.0mg Semaglutide 4-6 months at prescribed dose
Semaglutide (1 Mg Dose): Weekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Early Study Closure | 2 | 1 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
RATE OF PARTIAL REMISSION OF DIABETES
HbA1C \< 6.5%, fasting glucose \<125 mg/dl, or no medications or active treatment for one year
Time frame: 11 months
Population: Due to low recruitment numbers (\>5), no data analysis was completed because total number of patients recruited is too low to ensure patient confidentiality.
Secondary
RATE OF COMPLETE REMISSION OF DIABETES
HbA1C \< 6.0%, fasting glucose \<100 mg/dl, or no medications or active treatment for o
Time frame: 11 months
Population: Due to low recruitment numbers (\>5), no data analysis was completed because total number of patients recruited is too low to ensure patient confidentiality.