Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes

Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00411892

Enrollment

196

Registered

2006-12-15

Start date

2006-11-29

Completion date

2008-03-18

Last updated

2018-09-05

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

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone.

Detailed description

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Interventions

DRUGpioglitazone

Tablets, 45 mg/day.

DRUGinhaled human insulin

Treat-to-target dose titration scheme, inhalation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * Current treatment with oral antidiabetes drugs (OADs) for at least 2 months * HbA1c between 7.0-11.0% if on OAD monotherapy * HbA1c between 7.0-10.0% if on OAD combination therapy * BMI less than or equal to 40 kg/m2

Exclusion criteria

* Current regular smoking or regular smoking within the last 6 months * Current acute or chronic pulmonary disease (except for asthma) * Proliferative retinopathy requiring treatment * Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity * Pregnancy

Design outcomes

Primary

Measure	Time frame
HbA1c change from baseline	After 26 weeks of treatment

Secondary

Measure	Time frame
Fasting plasma glucose	after 26 weeks of treatment
Lipid profiles	after 26 weeks of treatment
Frequency of hypoglycaemic episodes	after 26 weeks of treatment
Glucose profiles	at pre- and post meals, bedtime and 3:00 am
Change in body weight	after 26 weeks of treatment

Countries

United States

Outcome results

None listed

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