US Inhaled Insulin Dose Titration Study

Study Overview
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Brief Summary
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This study will examine how to dose Exubera (inhaled insulin) in patients who are not well controlled on two or more diabetes pills. This study should show that a large number of patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that have been set by the American Diabetes Association (ADA). Target goals should be achieved by adjusting the Exubera dose either weekly or twice weekly. Patients will also receive nutritional counseling and diabetes education as part of the study.

Official Title
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A Randomized, Open-Label, Multicenter Study Assessing the Effects of Forced Exubera Dose Titration on Glycemic Control in Patients With Suboptimally Controlled Type 2 Diabetes on Two or More Oral Antidiabetic Agents

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Exubera (inhaled insulin)
* Procedure: 8-point glucose diary (to assess pre- and post prandial glucoses)
* Procedure: Meal Tolerance Test
* Procedure: 24-hour continuous glucose monitoring (at select sites)
* Procedure: Pulmonary Function Testing
* Procedure: Hypoglycemic Event Monitoring
* Procedure: Laboratory Assessments
* Behavioral: Nutritional Counseling and Diabetes Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female, age >= 18 years and <= 80 years, with a diagnosis of type 2 diabetes made at least 6 months prior to study entry, with hemoglobin A1C 7.5-10% Currently treated with 2 or more oral antidiabetic agents (sulfonylureas, metformin, and/or thiazolidinediones) Exclusion Criteria: Type 1 diabetes Smoking within the past 6 months or significant pulmonary diseases

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Exubera (inhaled insulin)|nan|
|Procedure: 8-point glucose diary (to assess pre- and post prandial glucoses)|nan|
|Procedure: Meal Tolerance Test|nan|
|Procedure: 24-hour continuous glucose monitoring (at select sites)|nan|
|Procedure: Pulmonary Function Testing|nan|
|Procedure: Hypoglycemic Event Monitoring|nan|
|Procedure: Laboratory Assessments|nan|
|Behavioral: Nutritional Counseling and Diabetes Education|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with type 2 diabetes (A1C 7.5-10% on >= 2 oral agents) in each study arm (Exubera dosage adjusted 'once weekly' or 'twice weekly') that attain an A1C of <=7% with forced dose titration of Exubera at 6 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints include change in A1C, fasting and 2 hr PP glucose, 24-hr mean glucose measured by continuous glucose monitoring, weight, lipids, and markers of oxidative stress. Hypoglycemia will also be assessed. |  |  |