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

Phase 3

Terminated

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: inhaled human insulin; Drug: rosiglitazone; Drug: glimepiride

• Registration Number: NCT00343980
• Lead Sponsor: Novo Nordisk A/S

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.

Study Timeline

• Study First Submitted: 2006-06-22
• Study First Submitted QC: 2006-06-22
• Study First Posted: 2006-06-23
• Study Start: 2006-10-10
• Primary Completion: 2008-03-10
• Study Completion: 2008-03-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 363

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	inhaled human insulin	-
A	glimepiride	-
B	rosiglitazone	-
B	glimepiride	-

Primary Outcome Measures

Name	Time	Method
Treatment difference in HbA1c	After 26 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇷 Istanbul, Turkey