Efficacy and Safety 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: metformin

• Registration Number: NCT00348712
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe.

The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin 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: 2006-07-05
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-06
• Study Start: 2006-10-30
• Primary Completion: 2008-03-05
• Study Completion: 2008-03-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• Type 2 diabetes
• Treated with OAD(s) for more than or equal to 2 months
• Body mass index of (BMI) less than or equal to 40.0 kg/m2
• HbA1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in OAD monotherapy and HbA1c greater than or equal to 7.0% 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 disorders
• Uncontrolled hypertension
• Proliferative retinopathy or maculopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Treatment difference in HbA1c	After 26 weeks

Secondary Outcome Measures

Name	Time	Method
Lung function	For the duration of the trial
Adverse events	For the duration of the trial
Body weight	For the duration of the trial
Blood glucose	For the duration of the trial
Hypoglycaemia	For the duration of the trial

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 York, United Kingdom