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

NCT ID: NCT00411892

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-29

Study Completion Date

2008-03-18

Brief Summary

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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

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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.

Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

pioglitazone

Intervention Type DRUG

Tablets, 45 mg/day.

inhaled human insulin

Intervention Type DRUG

Treat-to-target dose titration scheme, inhalation.

B

Group Type ACTIVE_COMPARATOR

pioglitazone

Intervention Type DRUG

Tablets, 45 mg/day.

Interventions

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pioglitazone

Tablets, 45 mg/day.

Intervention Type DRUG

inhaled human insulin

Treat-to-target dose titration scheme, inhalation.

Intervention Type DRUG

Other Intervention Names

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NN1998

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Ozark, Alabama, United States

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Tuscaloosa, Alabama, United States

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Vestavia Hills, Alabama, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Bermuda Dunes, California, United States

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Escondido, California, United States

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Fresno, California, United States

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Huntington Beach, California, United States

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La Jolla, California, United States

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Northridge, California, United States

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Orange, California, United States

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Orange, California, United States

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Poway, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Santa Barbara, California, United States

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Temecula, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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Arvada, Colorado, United States

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Colorado Springs, Colorado, United States

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Beverly Hills, Florida, United States

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Lake Mary, Florida, United States

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Marianna, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Niceville, Florida, United States

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Palm Harbor, Florida, United States

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Panama City, Florida, United States

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Pembroke Pines, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

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Athens, Georgia, United States

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Chesterfield, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Syracuse, New York, United States

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Charlotte, North Carolina, United States

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High Point, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Canal Fulton, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Clinton, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Altoona, Pennsylvania, United States

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Beaver, Pennsylvania, United States

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Bensalem, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Greer, South Carolina, United States

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Clarksville, Tennessee, United States

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Kingsport, Tennessee, United States

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Arlington, Texas, United States

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Lewisville, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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St. George, Utah, United States

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Arlington, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Warrenton, Virginia, United States

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Tacoma, Washington, United States

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Countries

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United States

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN1998-1683

Identifier Type: -

Identifier Source: org_study_id

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