Primary outcome· 11 months
RATE OF PARTIAL REMISSION OF DIABETES
| Group | Value |
|---|---|
| Control Arm | not posted |
| Test Arm | not posted |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataTreatment of GLP-1 for Diabetic Bariatric Patients
Short name NOVO-GLP1
This trial was stopped early.
Reason given at the registry: Poor enrollment
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 4
- Enrollment
- 3 participants (actual)
- Sponsor
- Geisinger Clinic · Other
- Design
- Randomized · Single masking
- Countries
1 country
United States
- Start
- 25 Aug 2021
- Primary completion
- 18 Jul 2022
- Completion
- 17 Aug 2022
- First posted
- 12 Nov 2020
- Last update posted
- 14 Nov 2023
- Conditions
- Diabetes Mellitus, Type 2
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
202120222023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Semaglutide (1 Mg Dose)Drug
- PlaceboDrug
Arms2
Placebo comparator
Control Arm
Once weekly injection of placebo 4-6 months at prescribed dose
Active comparator
Test Arm
Once weekly injection of 1.0mg Semaglutide 4-6 months at prescribed dose
Primary outcomes1
Outcomes the sponsor listed as primary.
RATE OF PARTIAL REMISSION OF DIABETES
Time frame · 11 months
Registry description
HbA1C \< 6.5%, fasting glucose \<125 mg/dl, or no medications or active treatment for one year
Secondary outcomes(1)
RATE OF COMPLETE REMISSION OF DIABETES
Time frame · 11 months
Registry description
HbA1C \< 6.0%, fasting glucose \<100 mg/dl, or no medications or active treatment for o
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcome· 11 months
RATE OF COMPLETE REMISSION OF DIABETES
| Group | Value |
|---|---|
| Control Arm | not posted |
| Test Arm | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Control ArmOnce 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 / 2 | 0 / 2 | 0 / 2 |
| Test ArmOnce 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 / 1 | 0 / 1 | 0 / 1 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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