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

Novo Nordisk

Status and phase: Terminated; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: pioglitazone; Drug: inhaled human insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411892

NN1998-1683

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: inhaled human insulin

Drug: pioglitazone

B

Active Comparator group

Treatment:

Drug: pioglitazone