Clinical trial for Type 1 Diabetes Mellitus
Official title Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes
ClinicalTrials.gov ID: NCT06609356
What this study is testing
What is Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor?
Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for type 1 diabetes mellitus.
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 study wants to find out whether lowering insulin with an SGLT2 inhibitor improves heart health and blood‑sugar control in type 1 diabetes. It will also compare these effects with people who have GCK‑MODY diabetes and with healthy volunteers.
- Who it's for
- Adults with type 1 diabetes (the study also includes small groups of people with GCK‑MODY diabetes and healthy volunteers).
- What's involved
- Participants will take an SGLT2 inhibitor medication and attend study visits where blood sugar, insulin needs, and heart‑related measurements are taken under high‑insulin and normal‑insulin conditions.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Age: 18-60 years BMI: 18-28 kg/m² Weight: ≥ 50 kg
- Duration of T1DM: 1-30 years HbA1c: 5.7-7.5% Insulin Therapy: Using automated insulin delivery
- HbA1c: 5.7-7.5% Genetic Confirmation: Positive GCK sequencing
- HbA1c: less than 5.5%
You likely can't join if
- Any hospital admissions for diabetic ketoacidosis in the past 6 months
- SBP greater than 140 mmHg and DBP greater than 100 mmHg
- eGFR by MDRD equation of less than 60 mL/min/1.73 m²
- AST or ALT greater than 2.5 times ULN
- Any antioxidant vitamin supplement within 2 weeks before the study
- Any systemic glucocorticoid
See the full eligibility criteria
- Age: 18-60 years BMI: 18-28 kg/m² Weight: ≥ 50 kg
- Duration of T1DM: 1-30 years HbA1c: 5.7-7.5% Insulin Therapy: Using automated insulin delivery
- HbA1c: 5.7-7.5% Genetic Confirmation: Positive GCK sequencing
- HbA1c: less than 5.5%
- Any hospital admissions for diabetic ketoacidosis in the past 6 months
- SBP greater than 140 mmHg and DBP greater than 100 mmHg
- eGFR by MDRD equation of less than 60 mL/min/1.73 m²
- AST or ALT greater than 2.5 times ULN
- Any antioxidant vitamin supplement within 2 weeks before the study
- Any systemic glucocorticoid
- Antipsychotics
- Atenolol, Metoprolol, Propranolol
- Niacin
- Any thiazide diuretic
- Any oral contraceptive pill with greater than 35 mcg ethinyl estradiol
- Growth hormone
- Any immunosuppressant
- Antihypertensive
- Pregnancy
- Tanner stage less than 5
- Peri- or post-menopausal women
- Active smoker T1DM Participants: Medications: Any diabetes medication except insulin C-peptide: greater than 0.7 ng/mL (fasting) GCK-MODY Participants: None specific
The study team makes the final eligibility decision.
Where it is enrolling
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.