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New treatment option for Type 1 Diabetes
Official title Acetazolamide in Persons With Type 1 Diabetes - Crossover Trial
ClinicalTrials.gov ID: NCT06981234
What this study is testing
What is Acetazolamide?
Acetazolamide is an investigational medicine, given as an once-daily infusion into a vein, 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 learn about the effect of the study drug acetazolamide in individuals with Type 1 Diabetes. Specifically, whether acetazolamide provides benefits to the kidneys while minimizing any side effects of the drug.
- Phase 2: a mid-size study of how well it works
- 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 18 and older
You may be able to join if
- Males and Females ≥ 18 years at the time of consent.
- Individuals able to become pregnant of non-child bearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile...
- Individuals able to cause a pregnancy must be willing to use clinically acceptable method of contraception during the entire study.
- Have a clinical diagnosis of Type 1 Diabetes on a stable medication regimen for at least 3 months.
- eGFR (estimated glomerular filtration rate) ≥ 45ml/min/1.73m2
You likely can't join if
- History of allergic reaction to acetazolamide, another carbonic anhydrase inhibitor, or any of the inactive ingredients in the acetazolamide tablets.
- Liver disease (clinical diagnosis of cirrhosis by imaging of physician; \> 14 drinks/week; AST (Aspartate Transferase), ALT (Alanine...
- Serum hemoglobin A1c \> 10.0%
- Serum hemoglobin concentration of \<8 g/dL.
- Use of \> 4 anti-hypertensives, or systolic blood pressure \>160mm Hg at the screening visit.
- Use of loop, thiazide or potassium sparing diuretics.
See the full eligibility criteria
- Males and Females ≥ 18 years at the time of consent.
- Individuals able to become pregnant of non-child bearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Individuals of child bearing potential must agree to use two methods of...
- Individuals able to cause a pregnancy must be willing to use clinically acceptable method of contraception during the entire study.
- Have a clinical diagnosis of Type 1 Diabetes on a stable medication regimen for at least 3 months.
- eGFR (estimated glomerular filtration rate) ≥ 45ml/min/1.73m2
- Serum bicarbonate ≥ 24 meq/L
- Negative urine toxicology screen.
- Able to provide written informed consent approved by an Institutional Review Board (IRB).
- History of allergic reaction to acetazolamide, another carbonic anhydrase inhibitor, or any of the inactive ingredients in the acetazolamide tablets.
- Liver disease (clinical diagnosis of cirrhosis by imaging of physician; \> 14 drinks/week; AST (Aspartate Transferase), ALT (Alanine Aminotransferase), or total bilirubin \> 2 times the upper limit of normal).
- Serum hemoglobin A1c \> 10.0%
- Serum hemoglobin concentration of \<8 g/dL.
- Use of \> 4 anti-hypertensives, or systolic blood pressure \>160mm Hg at the screening visit.
- Use of loop, thiazide or potassium sparing diuretics.
- A medical condition requiring active surgical or medical intervention whose urgency would preclude participation in this study at the discretion of the site investigator (active cardiac or pulmonary conditions, ongoing...
- Institutionalized individual (prisoners, patients with signification mental illness, or nursing home residents).
- Active pregnancy, breastfeeding, or planning to become pregnant during the study period.
- Current participation in another clinical trial (observational studies are exempted) trial.
- In the opinion of the investigators, inability to adhere to the study medical regimen or comply with recommendations.
- Inability or unwillingness to travel to study visits.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Compensation & support
A stipend or compensation may be offered.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, 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.