Status:
TERMINATED
Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
Lead Sponsor:
Mannkind Corporation
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 concurre...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00332826
Start Date
June 1 2006
End Date
October 1 2007
Last Update
May 4 2012
Active Locations (78)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85023
2
Northwest Medical Center
Phoenix, Arizona, United States, 85029
3
Premiere Pharmaceutical Research LLC
Tempe, Arizona, United States, 85282
4
Canyon Internal Medicine
Tucson, Arizona, United States, 85712