Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.

Efficacy And Safety Of Exubera (Inhaled Insulin) Therapy In Subjects With Type 2 Diabetes Mellitus Not Well Controlled With Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00370565

Enrollment

345

Registered

2006-08-31

Start date

1999-06-30

Completion date

2000-09-30

Last updated

2007-02-13

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

To assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.

Interventions

DRUGInhaled Human Insulin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Type 2 Diabetes Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier. * Patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin).

Exclusion criteria

* Asthma, COPD * Smoking during the previous 6 months

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.	—
HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values.	—

Secondary

Measure	Time frame
These results for efficacy are measured in the lab using plasma samples collected during clinic visits,	—
not the subject's home glucose monitoring results.	—
Comparison of 24-hour home glucose profiles.	—
Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies)	—
Meal glucose response measured at Week -1 and at Week 12;	—
Proportion of subjects with acceptable or good glycemic control (e.g., HbA1c < 8.0% or <7.0%) at the end of treatment, incidence and severity of hypoglycemic episodes, discontinuation rate, change in fasting lipid profile, and change in body weight.	—
A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026