Acetazolamide in Persons With Type 1 Diabetes - Crossover Trial

NCT06981234 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 802153-2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (4)

• Change in mGFR percent

  The difference in mGFR percent between acetazolamide versus placebo as measured by the iohexol procedure.

  10 weeks

• Preservation of Serum Bicarbonate

  The preservation of serum bicarbonate concentrations at ≥ 20 meq/L (milliequivalents per liter) from pre-dosing to post-treatment iohexol procedure.

  10 weeks

• Preservation of Serum Potassium

  The preservation of serum potassium concentrations at ≥ 3.2 meq/L from pre-dosing to post-treatment.

  10 weeks

• Change is albuminuria

  The difference in change in albuminuria between acetazolamide versus placebo as measured by urinalysis.

  10 weeks

Study Arms (2)

Treatment Group A

EXPERIMENTAL

250mg Acetazolamide administered twice a day for 10 weeks followed by Placebo Comparator administered twice a day for 10 weeks.

Drug: Acetazolamide; Drug: Placebo

Treatment Group B

EXPERIMENTAL

Placebo Comparator administered twice a day for 10 weeks followed by 250mg Acetazolamide administered twice a day for 10 weeks.

Drug: Acetazolamide; Drug: Placebo

Interventions

Acetazolamide DRUG

Acetazolamide is a potent carbonic anhydrase inhibitor that acts on the renal proximal tubule. Through this mechanism, it inhibits proximal tubule sodium reabsorption.

Treatment Group A; Treatment Group B

Placebo DRUG

Standard pharmaceutical filler will be capsulated and packaged identically to the acetazolamide.

Treatment Group A; Treatment Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 of child bearing potential must agree to use two methods of contraception during the entire study.
• 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).

You may not qualify 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 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 ischemia or cardiac symptoms, uncorrected Coronary Artery Disease (CAD) or decompensated congestive heart failure (CHF)).
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Breakthrough T1D: collaborator

Study Sites (1)

UC San Diego Altman Clinical & Translational Research Institute

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Todd May, MS

CONTACT

858-246-2146; t1dresearch@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, Double-blind, Placebo-Controlled, Crossover Trial

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: August 14, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)