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Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

NCT ID: NCT00322257

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

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-01

Study Completion Date

2008-04-02

Brief Summary

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This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes.

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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 1

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

inhaled human insulin

Intervention Type DRUG

Treat-to-target dose titration scheme, inhalation.

insulin detemir

Intervention Type DRUG

Injection s.c., 50% of daily dose

B

Group Type ACTIVE_COMPARATOR

insulin detemir

Intervention Type DRUG

Injection s.c., 50% of daily dose

insulin aspart

Intervention Type DRUG

Treat-to-target dose titration scheme, injection s.c.

Interventions

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inhaled human insulin

Treat-to-target dose titration scheme, inhalation.

Intervention Type DRUG

insulin detemir

Injection s.c., 50% of daily dose

Intervention Type DRUG

insulin aspart

Treat-to-target dose titration scheme, injection s.c.

Intervention Type DRUG

Other Intervention Names

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Levemir, NN304

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes
* HbA1c less than or equal to 11%
* Body mass index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria

* Total daily insulin dosage more than 100 IU or U/day.
* Current smoking or smoking within the last 6 months
* Impaired hepatic or renal function
* Cardiac problems
* Uncontrolled hypertension
* Current proliferative retinopathy or maculopathy requiring acute treatment
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

Birmingham, Alabama, United States

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Novo Nordisk Investigational Site

Tuscaloosa, Alabama, United States

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Concord, California, United States

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Encino, California, United States

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Escondido, California, United States

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Fresno, California, United States

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Inglewood, California, United States

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La Jolla, California, United States

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Mission Viejo, California, United States

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Poway, California, United States

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San Mateo, California, United States

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Santa Barbara, California, United States

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Tustin, California, United States

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Vista, California, United States

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Walnut Creek, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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New Britain, Connecticut, United States

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Norwalk, Connecticut, United States

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Waterbury, Connecticut, United States

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Boca Raton, Florida, United States

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Hollywood, Florida, United States

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Lake Mary, Florida, United States

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Melbourne, Florida, United States

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Merritt Island, Florida, United States

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Miami, 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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Atlanta, Georgia, United States

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Savannah, Georgia, United States

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Honolulu, Hawaii, United States

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Honolulu, Hawaii, United States

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Idaho Falls, Idaho, United States

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Chicago, Illinois, United States

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Peoria, Illinois, United States

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Springfield, Illinois, United States

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Lafayette, Indiana, United States

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New Albany, Indiana, United States

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Des Moines, Iowa, United States

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Shawnee Mission, Kansas, United States

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Topeka, Kansas, United States

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Lexington, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Scarborough, Maine, United States

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Hyattsville, Maryland, United States

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Springfield, Massachusetts, United States

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Waltham, Massachusetts, United States

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Bloomington, Minnesota, United States

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Duluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Tupelo, Mississippi, United States

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Jefferson City, 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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Butte, Montana, United States

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Omaha, Nebraska, United States

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Dover, New Hampshire, United States

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Hampton, New Hampshire, United States

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Lawrenceville, New Jersey, United States

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Albany, New York, United States

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New Hyde Park, New York, United States

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Rochester, New York, United States

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Asheville, North Carolina, United States

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Greenville, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Mentor, Ohio, United States

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Medford, Oregon, United States

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Hershey, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Olympia, Washington, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Gatineau, , Canada

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Mississauga, , Canada

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Penticton, , Canada

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Red Deer, , Canada

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St. John's, , Canada

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Novo Nordisk Investigational Site

Vancouver, , Canada

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Countries

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United States Canada

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN1998-2076

Identifier Type: -

Identifier Source: org_study_id

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