Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma
Conditions
Keywords
Inhaled insulin, Diabetes Type I and II with Asthma
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.
Interventions
Sponsors
Mannkind Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period | — |
Countries
Argentina, Brazil, Canada, Czechia, Mexico, Poland, Russia, Spain, Ukraine, United Kingdom, United States
Outcome results
None listed