Acetazolamide in Persons With Type 1 Diabetes - Dose Finding

Korábbi kezelés

• Hospitalization within 60 days prior to screening.

Más betegség

• History of allergic reaction to acetazolamide, another carbonic anhydrase inhibitor, or any of the inactive ingredients in the acetazolamide tablets.
• 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 CAD (coronary artery disease) or decompensated CHF(congestive heart failure)}.
• Institutionalized individual (prisoners, patients with signification mental illness, or nursing home residents).

Laborértékek

• Liver disease (clinical diagnosis of cirrhosis by imaging of physician; > 14 drinks/week; AST (aspartate aminotransferase), 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 loop, thiazide or potassium sparing diuretics.

Egyéb

• Use of > 4 anti-hypertensives, or systolic blood pressure >160mm Hg at the screening visit.
• Active pregnancy, breastfeeding, or planning to become pregnant during the study period.
• Current participation in another clinical trial (observational studies are exempted).
• 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.
• Life expectancy < 1 year.
• A plan to leave the geographical area within 6 months.

• Males and Females ≥ 18 years at the time of consent.
• Females of non-child bearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception during the entire study.
• Male subjects 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).