Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes

Phase 3

Terminated

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

• Registration Number: NCT00411892
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone.

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: 2006-11-29
• Study First Submitted: 2006-12-14
• Study First Submitted QC: 2006-12-14
• Study First Posted: 2006-12-15
• Primary Completion: 2008-03-18
• Study Completion: 2008-03-18
• Status Verified: 2018-09
• Disposition First Submitted: 2018-09-03
• Disposition First Submitted QC: 2018-09-03
• Last Update Submitted: 2018-09-03
• Disposition First Posted: 2018-09-05
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Type 2 diabetes
• Current treatment with oral antidiabetes drugs (OADs) for at least 2 months
• HbA1c between 7.0-11.0% if on OAD monotherapy
• HbA1c between 7.0-10.0% if on OAD combination therapy
• BMI less than or equal to 40 kg/m2

Exclusion Criteria

• Current regular smoking or regular smoking within the last 6 months
• Current acute or chronic pulmonary disease (except for asthma)
• Proliferative retinopathy requiring treatment
• Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	pioglitazone	-
A	inhaled human insulin	-
B	pioglitazone	-

Primary Outcome Measures

Name	Time	Method
HbA1c change from baseline	After 26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Frequency of hypoglycaemic episodes	after 26 weeks of treatment
Change in body weight	after 26 weeks of treatment
Fasting plasma glucose	after 26 weeks of treatment
Lipid profiles	after 26 weeks of treatment
Glucose profiles	at pre- and post meals, bedtime and 3:00 am

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Tacoma, Washington, United States