US Inhaled Insulin Dose Titration Study

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00246623

Enrollment

120

Registered

2005-10-31

Start date

2005-11-30

Completion date

2007-03-31

Last updated

2008-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

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.

Interventions

DRUGExubera (inhaled insulin)

PROCEDURE8-point glucose diary (to assess pre- and post prandial glucoses)

PROCEDUREMeal Tolerance Test

PROCEDURE24-hour continuous glucose monitoring (at select sites)

PROCEDUREPulmonary Function Testing

PROCEDUREHypoglycemic Event Monitoring

PROCEDURELaboratory Assessments

BEHAVIORALNutritional Counseling and Diabetes Education

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	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

Measure	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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026