Acetazolamide - 250mg Dose for Type 1 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UC San Diego Altman Clinical & Translational Research Institute, La Jolla, CA
Type 1 Diabetes Mellitus+2 More
Acetazolamide - Drug
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

1 of 3

Other trials for Type 1 Diabetes Mellitus

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

1 of 3

Other trials for Type 1 Diabetes Mellitus

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: Drug
Acetazolamide - 125mg Dose
Drug
Experimental Group · 1 Intervention: Acetazolamide · Intervention Types: Drug
Acetazolamide - 62.5mg Dose
Drug
Experimental Group · 1 Intervention: Acetazolamide · Intervention Types: Drug
Treatment
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
Photo of La Jolla  1Photo of La Jolla  2Photo of La Jolla  3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.