Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
- Conditions
- Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Asthma
- Registration Number
- NCT00332826
- Lead Sponsor
- Mannkind Corporation
- Brief Summary
The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines
- Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
- Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents)
- Subjects must exhibit <30% variability in PEF measurements during the 2 week run in period.
- Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period
- Body mass index (BMI) < 40kg/m2
- HbA1c >6.0% to <11.5%
- Severe complications of diabetes in the opinion of the investigator
- Seizure disorder
- Significant cardiovascular dysfunction and/or history within 3 months of screening
- Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure >110 mm HG at screening despite pharmacologic therapy.
- Clinical nephrotic syndrome or renal dysfunction or disease
- Total daily insulin requirement of >1.4 U/kg body weight
- Clinical diagnosis of Step 4 asthma
- Use of >6 puffs/day of fast acting bronchodilator
- Currently using an insulin delivery pump
- Use of Pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening
- Two or more severe hypoglycemic episodes within the past 6 months.
- Any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening.
- Current use of systemic steroids
- Subjects who currently smoke tobacco or who have smoked within the past 6 months
- Urine cotinine test of > 100ng/ml
- Current drug or alcohol abuse
- Clinically significant abnormalities on screening laboratory evaluation
- Cancer within the past 5 years or any history of lung neoplasms
- History of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes.
- Active infection or history of severe infection with 30 days of screening.
- Anemia
- History of anaphylaxis and/or angioneurotic edema
- Diagnosis of chronic obstructive pulmonary disease (COPE)
- Previous exposure to any inhaled insulin product
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (77)
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Northwest Medical Center
🇺🇸Phoenix, Arizona, United States
Premiere Pharmaceutical Research LLC
🇺🇸Tempe, Arizona, United States
Canyon Internal Medicine
🇺🇸Tucson, Arizona, United States
Associated Pharmaceutical Research Center Inc
🇺🇸Buena Park, California, United States
Family Medical Center
🇺🇸Foothill Ranch, California, United States
Health Care Partners Medical Group
🇺🇸Long Beach, California, United States
Golden Pine Clinical Research
🇺🇸Long Beach, California, United States
Keck USC School of Medicine
🇺🇸Los Angeles, California, United States
Pinaccle Trials Inc (SMO)
🇺🇸Atlanta, Georgia, United States
Scroll for more (67 remaining)Arizona Research Center🇺🇸Phoenix, Arizona, United States