Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

MannKind

Status and phase

Terminated

Phase 3

Conditions

Diabetes Mellitus, Type 1

Asthma

Diabetes Mellitus, Type 2

Treatments

Drug: Technosphere Insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00332826

MKC-TI-105

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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