Acetazolamide for Type 1 Diabetes

Overseen By Todd May, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Must not be taking: Diuretics

Disqualifiers: Liver disease, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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. These changes will be measured by laboratory tests that tell us how well the kidneys are functioning.

Eligibility Criteria

This trial is for people with Type 1 Diabetes who are interested in how a drug called acetazolamide might help their kidneys. The details on specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Negative urine toxicology screen

I am either post-menopausal, surgically sterile, or willing to use two forms of birth control.

eGFR (estimated glomerular filtration rate) ≥ 45ml/min/1.73m2

Exclusion Criteria

Serum hemoglobin A1c > 10.0%

I have liver disease or drink more than 14 alcoholic beverages a week.

Serum hemoglobin concentration of <8 g/dL

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 250mg acetazolamide or placebo twice daily for 10 weeks in a crossover design

10 weeks

Regular visits for drug administration and monitoring

Washout

Participants receive no study drug for 2 weeks between treatment periods

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Acetazolamide

Trial Overview The study is testing the effects of acetazolamide versus a placebo on kidney function in individuals with Type 1 Diabetes. It's a crossover trial, meaning each participant will receive both the drug and the placebo at different times to compare results.

Participant Groups

Group I: Acetazolamide 250mg BID Experimental Treatment 2 Interventions

250mg Acetazolamide administered twice a day for 10 weeks.

Group II: Placebo Comparator BID Placebo Group 2 Interventions

Placebo comparator administered twice a day for 10 weeks.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Breakthrough T1D

Collaborator