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New treatment option for Type 1 Diabetes
Official title GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab
ClinicalTrials.gov ID: NCT06338553
What this study is testing
What is Semaglutide (Rybelsus®)?
Semaglutide (Rybelsus®) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for type 1 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 50
You may be able to join if
- Aims 1-3: Stage 2 T1DM with TZIELD® and GLP-1Ra
- 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
You likely can't join if
- Comorbidities:
- SBP \> 140 mmHg and DBP \> 100 mmHg
- eGFR by MDRD equation of \< 60 mL/min/1.73m2
- AST or ALT \> 2.5 times ULN
- Family history of medullary thyroid carcinoma
- Diagnosis of pancreatitis or gastroparesis within the past 3 years
See the full eligibility criteria
- Aims 1-3: Stage 2 T1DM with TZIELD® and GLP-1Ra
- 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)
- Comorbidities:
- SBP \> 140 mmHg and DBP \> 100 mmHg
- eGFR by MDRD equation of \< 60 mL/min/1.73m2
- AST or ALT \> 2.5 times ULN
- Family history of medullary thyroid carcinoma
- Diagnosis of pancreatitis or gastroparesis within the past 3 years
- Medications: Any diabetes medication, any antioxidant vitamin supplement (\ 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, antihypertensive, any antihyperlipidemic
- Other: pregnancy, peri- or post-menopausal women, active smoker Aim 4: Early Stage 3 T1DM with GLP-1Ra Monotherapy Inclusion Criteria
- Age: 12-50 years
- BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric)
- Early stage 3 T1DM with either
- 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
- Time of stage 3 diagnosis: within eight weeks of first study visit Exclusion Criteria
- DKA history: history of diabetic ketoacidosis requiring hospital admission
- Comorbidities:
- Family history of medullary thyroid carcinoma
- Diagnosis of pancreatitis or gastroparesis within the past 3 years
- Medications: Any diabetes medication, any antioxidant vitamin supplement (\ 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, antihypertensive, any antihyperlipidemic
- Other: pregnancy, peri- or post-menopausal women, active smoker
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.