Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

Phase 3

Terminated

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: inhaled human insulin; Drug: insulin detemir; Drug: insulin aspart

• Registration Number: NCT00331604
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.

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: 2006-05-24
• Study First Submitted QC: 2006-05-29
• Study First Posted: 2006-05-31
• Study Start: 2006-08-31
• Primary Completion: 2008-05-05
• Study Completion: 2008-05-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 618

Inclusion Criteria

• Type 2 diabetes
• Currently treated with insulin
• Body mass index of (BMI) less than or equal to 40.0 kg/m2
• HbA1c less than or equal to 11.0%

Exclusion Criteria

• Total daily insulin dosage less than or equal to 100 IU or U/day
• Current smoking or smoking within the last 6 months
• Cardiac problems
• Uncontrolled hypertension
• Current proliferative retinopathy or maculopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	insulin detemir	-
A	inhaled human insulin	-
C	insulin detemir	-
C	insulin aspart	-
B	insulin detemir	-
B	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Treatment difference in HbA1c	After 52 weeks

Secondary Outcome Measures

Name	Time	Method
Blood glucose	After 52, 104 and 116 weeks of treatment
Body weight	During treatment
Adverse events	For the duration of the trial
Lung function	After 52, 104 and 116 weeks of treatment
Hypoglycaemia	From 12 weeks of treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Wirral, Merseyside, United Kingdom