Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, 12-month Treatment, Multicenter, Randomized, Open-Label, Parallel Group Clinical Trial Comparing Prandial Subcutaneous Insulin With Prandial Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma

Intervention / Treatment
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* Drug: Technosphere Insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Technosphere Insulin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inhaled insulin, Diabetes Type I and II with Asthma