US Inhaled Insulin Dose Titration Study

Pfizer120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Diabetes Mellitus, Type 2

Interventions

Exubera (inhaled insulin)DRUG

8-point glucose diary (to assess pre- and post prandial glucoses)PROCEDURE

Meal Tolerance TestPROCEDURE

24-hour continuous glucose monitoring (at select sites)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (16)

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Los Angeles, California, United States

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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