Diabetes Mellitus, Type 1 study: Semaglutide Pen Injector
Official title Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
ClinicalTrials.gov ID: NCT05819138
What this study is testing
What is Semaglutide Pen Injector?
An investigational once‑weekly injectable medicine being studied as a potential treatment for adults with type 1 diabetes. Semaglutide is a GLP‑1 receptor agonist designed to increase insulin secretion, reduce glucagon release, and slow gastric emptying, which can help lower blood glucose levels.
Also referred to as Ozempic.
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
- This study is testing whether semaglutide (a medicine) improves heart and kidney function and insulin sensitivity in adults with type 1 diabetes.
- Who it's for
- You may be able to join if you are an adult with type 1 diabetes.
- What's involved
- You would take semaglutide tablets and have check-ups to measure heart, kidney and blood sugar. You may also have routine lab tests.
- Time commitment
- The study lasts several months with visits every few weeks.
- Phase 3: a large, late-stage 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 49
You may be able to join if
- Age 18-49 years
- 1) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis
- Insulin pump or automated insulin delivery systems
- Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2
- Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker...
You likely can't join if
- HbA1c \>9%, recent diabetic ketoacidosis (DKA) or hospitalization
- Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy
- History/family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), pancreatitis
- Current/planned pregnancy or nursing
- Uncontrolled thyroid disease or hypertension (HTN) (≥ 160/100 mm Hg despite optimal therapy)
- Use of other non-insulin diabetes medications, insulin sensitizing medications, or systemic steroids in past 3 months
See the full eligibility criteria
- Age 18-49 years
- 1) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis
- Insulin pump or automated insulin delivery systems
- Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2
- Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), statins, diuretics)
- BMI 20-45 kg/m2
- Adequate contraceptive method for females
- HbA1c \>9%, recent diabetic ketoacidosis (DKA) or hospitalization
- Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy
- History/family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), pancreatitis
- Current/planned pregnancy or nursing
- Uncontrolled thyroid disease or hypertension (HTN) (≥ 160/100 mm Hg despite optimal therapy)
- Use of other non-insulin diabetes medications, insulin sensitizing medications, or systemic steroids in past 3 months
- Use of atypical antipsychotics
- Significant systemic illness such as cancer
- Shellfish/iodine allergy (only exclusionary to iohexol clearance procedure)
- MRI or PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- Seattle, Washington, 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 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; Seattle, Washington, 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.