Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Official Title
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A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-optimally Controlled on Combination Metformin and a Secretagogue.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Technosphere Insulin
* Drug: Metformin & Secretagogues
* Drug: Technosphere Insulin & Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months Stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks. Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria HbA1c >or= to 7.5% and < or= to 11.0% BMI < or = to 40kg/m2. FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70% Exclusion Criteria: Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues within the preceding 12 weeks Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings Evidence of serious complications of diabetes (e.g. autonomic neuropathy)

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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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: Crossover 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, prandial<br>|
| Active Comparator: 2<br>Metformin & Secretagogues | Drug: Metformin & Secretagogues<br>* Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.<br>|
| Experimental: 3<br>Technosphere & Metformin | Drug: Technosphere Insulin & Metformin<br>* Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue |  | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue | (Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue) | Baseline to Week 12 | 
| Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment) |  | Week 24 |