A Phase 4 interventional study of Semaglutide (1 Mg Dose) and Placebo in Diabetes Mellitus, Type 2, sponsored by Geisinger Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by Geisinger Clinic · Phase 4, Interventional, and Treatment
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 3 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Geisinger Clinic is the lead sponsor of 125 studies on the registry; 21 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Once weekly injection of placebo 4-6 months at prescribed dose
Drug: Placebo
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
Also known as: semaglutide
Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery
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
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
| Milestone | Control Arm | Test Arm |
|---|---|---|
| Started | 2 | 1 |
| Completed | 0 | 0 |
| Not completed | 2 | 1 |
| Withdrew: Early study closure | 2 | 1 |
HbA1C \< 6.5%, fasting glucose \<125 mg/dl, or no medications or active treatment for one year
No measurements were reported for this outcome.
HbA1C \< 6.0%, fasting glucose \<100 mg/dl, or no medications or active treatment for o
No measurements were reported for this outcome.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Arm | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Test Arm | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
Due to low recruitment numbers (\>5), no data analysis was completed because total number of patients recruited is too low to ensure patient confidentiality.
| Age, Categorical | Control Arm | Test Arm | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Sex: Female, Male | Control Arm | Test Arm | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race (NIH/OMB) | Control Arm | Test Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | — | — |
| Asian | — | — | — |
| Native Hawaiian or Other Pacific Islander | — | — | — |
| Black or African American | — | — | — |
| White | — | — | — |
| More than one race | — | — | — |
| Unknown or Not Reported | — | — | — |
| Region of Enrollment | Control Arm | Test Arm | Total |
|---|
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Plan to share: No
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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