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

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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)

196 participants in 2 patient groups

A
Experimental group
Treatment:
Drug: inhaled human insulin
Drug: pioglitazone
B
Active Comparator group
Treatment:
Drug: pioglitazone

Trial contacts and locations

110

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Data sourced from clinicaltrials.gov

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