NCT06338553RecruitingEarly phase 1
GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab
Optimizing Stage 2 T1DM Management: Assessing the Impact of GLP-1Ra on Metabolic Outcomes in Patients Receiving Teplizumab
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
The goal of this study is to determine how a drug class called glucagon-like peptide-1 receptor agonists (GLP-1Ra) affects people during an early stage of Type 1 Diabetes undergoing clinical teplizumab treatment. This study involves giving participants a liquid meal under different conditions and observing how their bodies respond, focusing on blood sugar levels, insulin effectiveness, and blood vessel function. The meal tests are followed by two post-treatment tests, one with the GLP-1Ra drug and the other with a placebo. Each test involves blood draws before and during the meal test, GLP-1Ra or placebo administration, and an ultrasound to measure blood vessel function. The goal is to see if GLP-1Ra can help manage blood sugar levels and improve cardiovascular health in this population.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 7 Mar 2024
- Start date
- 12 Jun 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06338553
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 24
- From 12 Jun 2024 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medications: Any diabetes medication, any antioxidant vitamin supplement (\<2 weeks before a study), any systemic glucocorticoid, antipsychotic, atenolol, metoprolol, propranolol, niacin, any thiazide diuretic, any OCP with \> 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, antihypertensive, any antihyperlipidemic
- Medications: Any diabetes medication, any antioxidant vitamin supplement (\<2 weeks before a study), any systemic glucocorticoid, antipsychotic, atenolol, metoprolol, propranolol, niacin, any thiazide diuretic, any OCP with \> 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, antihypertensive, any antihyperlipidemic
Other illness
- Family history of medullary thyroid carcinoma
- DKA history: history of diabetic ketoacidosis requiring hospital admission
- Family history of medullary thyroid carcinoma
Lab values
- eGFR by MDRD equation of \< 60 mL/min/1.73m2
- AST or ALT \> 2.5 times ULN
- HbA1c 6.5% to 8.0% at diagnosis OR
- HbA1c 5.7% to 6.4% with oral glucose test meeting ADA criteria for stage 3 T1DM within the past three months prior to or during screening visit
Age
- Age: 12-50 years
Other
- Comorbidities:
- SBP \> 140 mmHg and DBP \> 100 mmHg
- Diagnosis of pancreatitis or gastroparesis within the past 3 years
- Other: pregnancy, peri- or post-menopausal women, active smoker
- Aim 4: Early Stage 3 T1DM with GLP-1Ra Monotherapy Inclusion Criteria
- BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric)
- Early stage 3 T1DM with either
- Time of stage 3 diagnosis: within eight weeks of first study visit
- Comorbidities:
- Diagnosis of pancreatitis or gastroparesis within the past 3 years
- Other: pregnancy, peri- or post-menopausal women, active smoker
Who the study is looking for
- Age: 12-50 years
- BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric)
- Stage 2 T1DM (i.e., ≥ 2 islet auto-antibodies and:
- fasting glucose ≥ 100 mg/dL and \< 126 mg/dL OR
- 2-hr OGTT /MMTT ≥ 140 mg/dL and \< 200 mg/dL OR
- During an OGTT having a glucose of \> 199 mg/dL at 30, 60, or 90 minutes)
Criteria the registry did not label
- Aims 1-3: Stage 2 T1DM with TZIELD® and GLP-1Ra
Age in the registry: 12 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.