Diabetes Mellitus, Type 2Phase 4NOVO-GLP1NCT04624672
Treatment of GLP-1 for Diabetic Bariatric Patients
A Phase 4 study testing Semaglutide (1 Mg Dose) in people with Diabetes Mellitus, Type 2, run by Geisinger Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide (1 Mg Dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2021to 17 Aug 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17822
About this study
Official title: GLP-1 Agonists as Neoadjuvant Therapy for Surgical Treatment of Type 2 Diabetes: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Semaglutide (1 Mg Dose), Placebo
- Keywords
- Bariatric Surgery, Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (1 Mg Dose)Drug
Also called semaglutide
Weekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery
PlaceboDrug
Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | Once weekly injection of placebo 4-6 months at prescribed dose Receives: Drug: Placebo |
| Test Arm | Active comparator | Once weekly injection of 1.0mg Semaglutide 4-6 months at prescribed dose Receives: Drug: Semaglutide (1 Mg Dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RATE OF PARTIAL REMISSION OF DIABETES
HbA1C < 6.5%, fasting glucose <125 mg/dl, or no medications or active treatment for one year
Measured: 11 months
Secondary outcomes (1)
RATE OF COMPLETE REMISSION OF DIABETES
HbA1C < 6.0%, fasting glucose <100 mg/dl, or no medications or active treatment for o
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start25 Aug 2021
- Primary completion18 Jul 2022
- Study completion17 Aug 2022
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Christopher Still, Geisinger Clinic
- Investigators
- Christopher Still, DO, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624672
- Sponsor's protocol ID
- 2020-0937
- Other IDs
- U1111-1242-4068
- Acronym
- NOVO-GLP1
- Status last verified
- Oct 2023
- First submitted
- 5 Nov 2020
- Last updated
- 14 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP-1 Agonists as Neoadjuvant Therapy for Surgical Treatment of Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04624672
- Acronym / sponsor ID
- NOVO-GLP1 / 2020-0937
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Bariatric Surgery, Semaglutide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Drug: PlaceboOnce weekly injection of placebo 4-6 months at prescribed dose |
| Test Arm | Active comparator | Drug: Semaglutide (1 Mg Dose)Once weekly injection of 1.0mg Semaglutide 4-6 months at prescribed dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide (1 Mg Dose)Also: semaglutideWeekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery | Drug | Test Arm |
| PlaceboWeekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery | Drug | Control Arm |
Primary outcome
RATE OF PARTIAL REMISSION OF DIABETES
Time frame: 11 months
HbA1C < 6.5%, fasting glucose <125 mg/dl, or no medications or active treatment for one year
1 secondary outcome
RATE OF COMPLETE REMISSION OF DIABETES
Time frame: 11 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Still, DO principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide (1 Mg Dose) in people with Diabetes Mellitus, Type 2, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RATE OF PARTIAL REMISSION OF DIABETES (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.