Status:
COMPLETED
Study to Estimate the Effects of Inhaled Versus Intravenous (IV) Infusion of Human Insulin in Subjects With Type 1 Diabetes
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Pfizer
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
A dry powder insulin formulation delivered by an aerosol inhaler has been in clinical development for use in types 1 and 2 diabetes mellitus (DM) and just recently (1-27-06) received approval from the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00315952
Start Date
April 1 2006
End Date
December 1 2006
Last Update
February 18 2008
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213