Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes

Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00469586

Acronym

iINHALE 7

Enrollment

174

Registered

2007-05-04

Start date

2007-04-26

Completion date

2008-04-24

Last updated

2017-03-01

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 Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

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

DRUGinhaled human insulin

Treat-to-target dose titration scheme, pre-prandial, inhalation.

DRUGmetformin

Tablets, 2000 mg/day.

DRUGglimepiride

Tablets, 4 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 * Treated with OADs for more than or equal to 3 months * HbA1c greater than or equal to 8.0% and less than or equal to 11.0% * Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion criteria

* Recurrent major hypoglycaemia * Current smoking or smoking within the last 6 months * Impaired hepatic or renal function * Cardiac problems * Uncontrolled hypertension * Proliferative retinopathy or maculopathy

Design outcomes

Primary

Measure	Time frame
HbA1c change from baseline	After 18 weeks of treatment

Secondary

Measure	Time frame
Adverse events	For the duration of the trial
Body weight	after 18 weeks of treatment
Lung function	after 18 weeks of treatment
Blood glucose	after 18 weeks of treatment
Hypoglycaemia	after 18 weeks of treatment

Countries

Argentina, Austria, Belgium, Bulgaria, Canada, France, India, Israel, Mexico, Poland, Turkey (Türkiye)

Outcome results

None listed

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