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Diuretic
Acetazolamide for Type 1 Diabetes
Phase 1 & 2
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of child bearing potential must agree to use two methods of contraception during the entire study
Have a clinical diagnosis of Type 1 Diabetes on a stable medication regimen for at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Study Summary
This trial is testing different doses of a drug to see what effect it has on kidney function. There will be 8 study visits over 16 weeks.
Who is the study for?
This trial is for adults with Type 1 Diabetes who have been on a stable medication regimen for at least 3 months, have an eGFR of ≥45 ml/min/1.73m2, and are not using certain diuretics or other exclusionary medications. Women must be non-childbearing or use two contraception methods; men need to use contraception too.Check my eligibility
What is being tested?
The study tests different doses of acetazolamide (62.5mg, 125mg, and 250mg twice daily) in escalating order with washout periods between each dose. Participants will undergo kidney function tests before and after each dosing period over approximately 16 weeks.See study design
What are the potential side effects?
Potential side effects of acetazolamide may include allergic reactions for those sensitive to the drug or its ingredients, blood chemistry changes like altered bicarbonate levels, and possibly others not listed here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use two forms of birth control during the study.
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I have Type 1 Diabetes and have been on a stable medication plan for over 3 months.
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I am a woman who cannot have children because I am either over 1 year post-menopausal or have been surgically sterilized.
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I am willing to use birth control throughout the study.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mGFR percent
Preservation of Serum Bicarbonate
Preservation of Serum Potassium
Side effects data
From 2022 Phase 4 trial • 11 Patients • NCT033770499%
External Ventricular Drainage infection
9%
Hydrocephalus
9%
Pulmonary edema
9%
Cardiomyopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acetazolamide Challenge
Trial Design
3Treatment groups
Experimental Treatment
Group I: Acetazolamide - 62.5mg DoseExperimental Treatment1 Intervention
2-week treatment period with 62.5mg dose of acetazolamide taken twice daily.
Group II: Acetazolamide - 250mg DoseExperimental Treatment1 Intervention
2-week treatment period with 250mg dose of acetazolamide taken twice daily.
Group III: Acetazolamide - 125mg DoseExperimental Treatment1 Intervention
2-week treatment period with 125mg dose of acetazolamide taken twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetazolamide
2011
Completed Phase 4
~2910
Find a Location
Who is running the clinical trial?
JDRFUNKNOWN
3 Previous Clinical Trials
50,053 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
55 Previous Clinical Trials
64,024 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,117 Previous Clinical Trials
1,520,276 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have liver disease, drink more than 14 alcoholic beverages a week, or have high liver enzyme levels.I agree to use two forms of birth control during the study.I have not been hospitalized in the last 60 days.I am taking water pills for my health condition.I have Type 1 Diabetes and have been on a stable medication plan for over 3 months.You had an allergic reaction to acetazolamide or similar medications in the past.I do not have urgent health issues that need immediate treatment.Your kidney function, measured by eGFR, is at least 45ml/min/1.73m2.Your blood bicarbonate level is 24 meq/L or higher.I take more than 4 blood pressure medications or my blood pressure was over 160 at my last check-up.I am a woman who cannot have children because I am either over 1 year post-menopausal or have been surgically sterilized.I am willing to use birth control throughout the study.People who are in prison, have significant mental illness, or live in a nursing home.I cannot or do not want to travel for study visits.Your blood hemoglobin level is less than 8 grams per deciliter.Your average blood sugar level (HbA1c) is higher than 10.0%.Your urine should not show any signs of drug use.You are expected to live for less than a year.You are planning to move away from the area within 6 months.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Acetazolamide - 125mg Dose
- Group 2: Acetazolamide - 62.5mg Dose
- Group 3: Acetazolamide - 250mg Dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for enrollment in this research endeavor?
"The clinicaltrials.gov database states that recruitment for this trial has ended after its listing on the 12th of December 2022, and subsequent update on November 9th 20222. Fortunately, there are still an abundance of other trials currently recruiting participants with a total number at 1,258."
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