A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.

Study Overview
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Brief Summary
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The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.

Official Title
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A 16 Week Open-Label Outpatient, Randomized, Parallel Study Assessing The Impact Of Two Different Initial Dose Prescriptions For Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Inhaled Human Insulin (Exubera)
* Drug: Inhaled Human Insulin (Exubera)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes mellitus Type 2 Currently treated with at least 2 oral anti-diabetic agents Exclusion Criteria: Severe Asthma, severe COPD Smoking

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Drug: Inhaled Human Insulin (Exubera)<br>* Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID<br>|
| Experimental: Experimental<br> | Drug: Inhaled Human Insulin (Exubera)<br>* Initial dose of 1mg TID of inhaled human insulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c From Baseline | Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16 | From baseline to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF) | Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values. | From baseline to week 16 | 
| Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia | Cumulative Number Subjects Who Experienced Hypoglycemia & Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms. | week 16 | 
| Hypoglycemia Event Rate Per Month | Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16). | up to week 4 or 16 |