Study to Estimate the Effects of Inhaled Versus Intravenous (IV) Infusion of Human Insulin in Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

University of Pittsburgh Medical Center (UPMC) diabetes research physicians are studying the action in muscle tissue of "inhaled" insulin (Exubera®) and "infused" (intravenous or IV) insulin on blood sugar control in people with type 1 diabetes. Type 1 diabetics often take 2-4 shots of insulin every day. Exubera may offer an alternative to these insulin injections.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: Pfizer
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Ages 18 to 50 years old

• Body mass index (BMI) 20 to 27 kg/m2 and a total body weight > 50 kg (110 lbs)

• Blood pressure: systolic < 150; diastolic < 95.

• Type 1 DM

• Have diagnosed diabetes type 1 for a minimum of 12 months prior to study entry

• In good general health with no evidence or history of clinically significant hematological, renal, endocrine (other than diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

• Hematocrit (Hct) > 34%

• ALT < 60; AST < 60

• Alkaline phosphatase (Alk Phos) < 150

• Sensitive thyroid-stimulating hormone (sTSH) < 6

• Fasting (morning) glucose 100-160 mg/dl

• Documented hemoglobin A1c (HbA1c) < 7.5% at time of entry

• Triglycerides < 175

• Cholesterol < 275

Exclusion Criteria:

• Exclude if unable to master use of the inhalation device after 3 attempts

• Exclude if positive urine drug screen

• Exclude if any episodes of severe hypoglycemia in the past 3 months

• Exclude if pregnant or breastfeeding or unwilling to use an acceptable method of non-hormonal contraception from at least 14 days prior to the first dose of Exubera® until study is completed.

• Exclude if any history of (h/o) asthma or chronic obstructive pulmonary disease (COPD)

• Exclude if forced expiratory volume in one second (FEV1) or forced vital capacity (FVC) < 70% predicted

• Exclude if treatment with an investigational drug within 30 days preceding the first dose of trial medication.

• Exclude if blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing

• Exclude if unable or unwilling to comply with the protocol as written

• Exclude if any use of tobacco or nicotine containing products within the past 6 months

• Exclude if history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of screening

• Exclude if claustrophobic, any surgical or vascular implants or pacemakers, or any metal in the body