US Inhaled Insulin Dose Titration Study

Pfizer

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00246623

A2171067

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)