Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

Study Overview
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Brief Summary
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To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Official Title
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A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up

Conditions
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Diabetes, Type I

Intervention / Treatment
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* Drug: Technosphere Insulin
* Drug: Active comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of type 1 diabetes for at least 1 year Nonsmokers for prior 6 months BMI less than or equal to 35kg/m2 HbA1c > or = 7% and < or = 11% Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects FEV1 > or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day Urine cotinine < or = 100 ng/mL Exclusion Criteria: History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings Evidence of severe complications of diabetes Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Technosphere Insulin | Drug: Technosphere Insulin<br>* Inhalation, 15U/30U<br>|
| Active Comparator: 2<br>Rapid-acting analogue insulin plus basal insulin glargine | Drug: Active comparator<br>* sc injectable insulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the Mean Change From Baseline to Week 52 in HbA1c |  | Baseline to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Weight to Week 52 | Change from baseline in weight at Week 52 | Baseline to Week 52 | 
| Change From Baseline in Fasting Plasma Glucose to Week 52 | Change from baseline in fasting plasma glucose at Week 52 | Baseline to Week 52 | 
| Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0% | Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0% | Baseline to Week 52 | 
| Incidence of Total Hypoglycemia | Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms. | Baseline to Week 52 | 
| Incidence of Severe Hypoglycemia | Severe hypoglycemia occurs when all 3 of the following occur simultaneously: Subject requires the assistance of another person; Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness); Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR, Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms. | Baseline to Week 52 | 
| Total Hypoglycemia Event Rate | Number of Hypoglycemic Events/Total Subject Exposure Time (in months) | Baseline to Week 52 | 
| Severe Hypoglycemia Event Rate | Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months) | Baseline to Week 52 |