Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes

Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride on HbA1c in Subjects With Type 2 Diabetes

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00427154

Enrollment

227

Registered

2007-01-26

Start date

2007-01-10

Completion date

2008-03-11

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 or rosiglitazone treatment, both in combination with metformin and glimepiride.

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

DRUGrosiglitazone

Tablets, 4 mg once or twice daily.

DRUGinhaled human insulin

Treat-to-target dose titration scheme, inhalation.

DRUGmetformin

Tablets, 2000 mg/day.

DRUGglimepiride

Tablets, 8 mg/day.

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 * Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months * HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy * BMI less than or equal to 40 kg/m2

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1c	After 26 weeks

Secondary

Measure	Time frame
Fasting plasma glucose	For the duration of the trial
Lipid profiles	For the duration of the trial
Hypoglycaemic episodes	For the duration of the trial
Glucose profiles	For the duration of the trial
Change in body weight	For the duration of the trial

Countries

United States

Outcome results

None listed

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