Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes

NCT ID: NCT00427154

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

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-10

Study Completion Date

2008-03-11

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 or rosiglitazone treatment, both in combination with metformin and glimepiride.

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 ACTIVE_COMPARATOR

inhaled human insulin

Intervention Type DRUG

Treat-to-target dose titration scheme, inhalation.

metformin

Intervention Type DRUG

Tablets, 2000 mg/day.

glimepiride

Intervention Type DRUG

Tablets, 8 mg/day.

B

Group Type ACTIVE_COMPARATOR

rosiglitazone

Intervention Type DRUG

Tablets, 4 mg once or twice daily.

metformin

Intervention Type DRUG

Tablets, 2000 mg/day.

glimepiride

Intervention Type DRUG

Tablets, 8 mg/day.

Interventions

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rosiglitazone

Tablets, 4 mg once or twice daily.

Intervention Type DRUG

inhaled human insulin

Treat-to-target dose titration scheme, inhalation.

Intervention Type DRUG

metformin

Tablets, 2000 mg/day.

Intervention Type DRUG

glimepiride

Tablets, 8 mg/day.

Intervention Type DRUG

Other Intervention Names

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NN1998

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months
* HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy
* BMI less than or equal to 40 kg/m2

Exclusion Criteria

* Current smoking or smoking within the last 6 months
* Current acute or chronic pulmonary disease (except for asthma)
* Proliferative retinopathy requiring acute treatment
* Clinically significant disease history including kidney or liver disease
* 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

Hueytown, Alabama, United States

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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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Concord, 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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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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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Waterbury, Connecticut, 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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Merritt Island, Florida, United States

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Miami, Florida, United States

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Palm Harbor, Florida, United States

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Pembroke Pines, 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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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Dunwoody, Georgia, United States

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Powder Springs, Georgia, United States

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Roswell, Georgia, United States

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Suwanee, Georgia, United States

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Tucker, Georgia, United States

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Honolulu, Hawaii, United States

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Boise, 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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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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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Marlborough, Massachusetts, United States

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Springfield, Massachusetts, United States

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Jackson, Mississippi, United States

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Chesterfield, Missouri, 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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Billings, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Cherry Hill, New Jersey, United States

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Lawrenceville, New Jersey, United States

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Staten Island, New York, United States

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Syracuse, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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High Point, North Carolina, 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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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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Norristown, Pennsylvania, United States

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Greer, South Carolina, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, 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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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Hurst, Texas, United States

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Lewisville, Texas, United States

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San Antonio, Texas, 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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Renton, Washington, 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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NN1998-1540

Identifier Type: -

Identifier Source: org_study_id

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