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TERMINATEDPhase 3NCT00411892

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

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 t...

Lead sponsor: Novo Nordisk A/S•110 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Novo Nordisk A/S

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 5, 2018Terms

Trial snapshot

StatusTERMINATED

PhasePHASE3

Enrollment196

Start dateNov 2006

Last updatedSep 5, 2018

Condition

Diabetes Diabetes Mellitus, Type 2

Locations shown

Novo Nordisk Investigational Site

Ozark, Alabama

Novo Nordisk Investigational Site

Tuscaloosa, Alabama

Novo Nordisk Investigational Site

Vestavia Hills, Alabama

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2018Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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