Acetazolamide - 250mg Dose for Type 1 Diabetes Mellitus
Phase-Based Progress Estimates
Effectiveness
Safety
UC San Diego Altman Clinical & Translational Research Institute, La Jolla, CA
Type 1 Diabetes Mellitus+2 More
Acetazolamide - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This is a dose finding trial where participants will receive escalating doses of acetazolamide, each for a 2-week dosing period followed by a 2-week washout period. The three doses examined will be open-label 62.5mg twice daily, 125mg twice daily, and 250mg twice daily of acetazolamide. A baseline Iohexol GFR (glomerular filtration rate) measurement will be performed prior to the first administration of each acetazolamide dose and then again following each dosing period. Including a screening visit and a follow-up visit, there will be a total of 8 study visits over approximately 16 weeks.
Eligible Conditions
- Type 1 Diabetes Mellitus
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: 2 Weeks
2 Weeks
Change in mGFR percent
Preservation of Serum Bicarbonate
Preservation of Serum Potassium
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Acetazolamide - 250mg Dose
1 of 3
Acetazolamide - 125mg Dose
1 of 3
Acetazolamide - 62.5mg Dose
1 of 3
Experimental Treatment
12 Total Participants · 3 Treatment Groups
Primary Treatment: Acetazolamide - 250mg Dose · No Placebo Group · Phase 1 & 2
Acetazolamide - 250mg Dose
Drug
Experimental Group · 1 Intervention: Acetazolamide · Intervention Types: DrugAcetazolamide - 125mg Dose
Drug
Experimental Group · 1 Intervention: Acetazolamide · Intervention Types: DrugAcetazolamide - 62.5mg Dose
Drug
Experimental Group · 1 Intervention: Acetazolamide · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetazolamide
2011
Completed Phase 4
~2760
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks
Trial Background
Prof. Jeremy Pettus, MD
Principal Investigator
University of California, San Diego
Closest Location: UC San Diego Altman Clinical & Translational Research Institute · La Jolla, CA
2021First Recorded Clinical Trial
5 TrialsResearching Type 1 Diabetes Mellitus
2 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are able to provide written informed consent.
You are at least 18 years old.
You are male and are willing to use clinically acceptable method of contraception during the entire study.
You have eGFR ≥ 45ml/min/1.73m2.
You have a serum bicarbonate of at least 24 meq/L.
You have Type 1 Diabetes and are taking a stable medication regimen for at least 3 months.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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