Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

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