Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00343980

Enrollment

363

Registered

2006-06-23

Start date

2006-10-10

Completion date

2008-03-10

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 Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (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

DRUGrosiglitazone

Tablets, 4 mg once or twice a day.

DRUGinhaled human insulin

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

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 OAD(s) for more than or equal to 2 months * Body mass index (BMI) less than or equal to 40.0 kg/m2 * HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy * HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy

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
Treatment difference in HbA1c	After 26 weeks

Secondary

Measure	Time frame
Adverse events	For the duration of the trial
Body weight	during treatment
Lung function	after 26 weeks of treatment
Blood glucose	after 26 weeks of treatment
Hypoglycaemia	from 12-26 weeks of treatment

Countries

Australia, Croatia, India, North Macedonia, Philippines, Russia, Turkey (Türkiye)

Outcome results

None listed

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