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

Phase 3

Terminated

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

• Registration Number: NCT00469586
• Lead Sponsor: Novo Nordisk A/S

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.

Study Timeline

• Study Start: 2007-04-26
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Primary Completion: 2008-04-24
• Study Completion: 2008-04-24
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	inhaled human insulin	-
B	inhaled human insulin	-
C	glimepiride	-
C	metformin	-

Primary Outcome Measures

Name	Time	Method
HbA1c change from baseline	After 18 weeks of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇷 Konya, Turkey