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

NCT00411892 | Terminated Phase 3

• 1 other identifier: NN1998-1683
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 110

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c change from baseline

  After 26 weeks of treatment

Secondary Outcomes (5)

• Fasting plasma glucose

  after 26 weeks of treatment

• Lipid profiles

  after 26 weeks of treatment

• Frequency of hypoglycaemic episodes

  after 26 weeks of treatment

• Glucose profiles

  at pre- and post meals, bedtime and 3:00 am

• Change in body weight

  after 26 weeks of treatment

Study Arms (2)

A

EXPERIMENTAL

Drug: pioglitazone; Drug: inhaled human insulin

B

ACTIVE COMPARATOR

Drug: pioglitazone

Interventions

pioglitazone DRUG

Tablets, 45 mg/day.

A; B

inhaled human insulin DRUG

Treat-to-target dose titration scheme, inhalation.

Also known as: NN1998

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (110)

Novo Nordisk Investigational Site

Ozark, Alabama, 36360, United States

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Tuscaloosa, Alabama, 35406, United States

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Vestavia Hills, Alabama, 35209, United States

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Tucson, Arizona, 85741, United States

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Little Rock, Arkansas, 72204, United States

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Bermuda Dunes, California, 92203, United States

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Escondido, California, 92025, United States

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Fresno, California, 93720, United States

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Huntington Beach, California, 92646, United States

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La Jolla, California, 92037, United States

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Northridge, California, 91325, United States

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Orange, California, 92868, United States

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Orange, California, 92869, United States

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Poway, California, 92064, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95821, United States

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San Diego, California, 92103-620, United States

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Santa Barbara, California, 93105, United States

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Temecula, California, 92591, United States

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Tustin, California, 92780, United States

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Walnut Creek, California, 94598, United States

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Arvada, Colorado, 80005, United States

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Colorado Springs, Colorado, 80904, United States

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Beverly Hills, Florida, 34465, United States

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Boca Raton, Florida, 33433, United States

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Clearwater, Florida, 33759, United States

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Hialeah, Florida, 33010, United States

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Hollywood, Florida, 33021, United States

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Lake Mary, Florida, 32746, United States

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Marianna, Florida, 32446, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33136, United States

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Niceville, Florida, 32578, United States

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Palm Harbor, Florida, 34684, United States

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Panama City, Florida, 32401, United States

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Pembroke Pines, Florida, 33029, United States

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St. Petersburg, Florida, 33709, United States

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Tallahassee, Florida, 32308, United States

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Vero Beach, Florida, 32960, United States

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West Palm Beach, Florida, 33401, United States

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Athens, Georgia, 30606, United States

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Atlanta, Georgia, 30342, United States

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Blue Ridge, Georgia, 30513, United States

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Dunwoody, Georgia, 30338, United States

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Powder Springs, Georgia, 30127, United States

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Roswell, Georgia, 30076, United States

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Sandy Springs, Georgia, 30328, United States

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Suwanee, Georgia, 30024, United States

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Tucker, Georgia, 30084, United States

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Honolulu, Hawaii, 96814, United States

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Boise, Idaho, 83702, United States

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Avon, Illinois, 46123, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60612, United States

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Peoria, Illinois, 61615, United States

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Lafayette, Indiana, 47904, United States

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Des Moines, Iowa, 50314, United States

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Topeka, Kansas, 66606, United States

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Wichita, Kansas, 67205, United States

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Lexington, Kentucky, 40503, United States

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Baltimore, Maryland, 21201, United States

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Prince Frederick, Maryland, 20678, United States

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Marlborough, Massachusetts, 01752, United States

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Waltham, Massachusetts, 02453, United States

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Bloomington, Minnesota, 55420, United States

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Jackson, Mississippi, 39216, United States

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Chesterfield, Missouri, 63017, United States

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Jefferson City, Missouri, 65109, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63141, United States

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Billings, Montana, 59102, United States

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Las Vegas, Nevada, 89109, United States

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Las Vegas, Nevada, 89128, United States

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Syracuse, New York, 13210, United States

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Charlotte, North Carolina, 28209, United States

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High Point, North Carolina, 27262, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Bismarck, North Dakota, 58501, United States

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Canal Fulton, Ohio, 44614, United States

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Cincinnati, Ohio, 45224, United States

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Cincinnati, Ohio, 45245, United States

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Cleveland, Ohio, 44115, United States

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Cleveland, Ohio, 44122, United States

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Dayton, Ohio, 45439, United States

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Clinton, Oklahoma, 73601, United States

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Oklahoma City, Oklahoma, 73104-5020, United States

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Medford, Oregon, 97504-8491, United States

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Altoona, Pennsylvania, 16602, United States

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Beaver, Pennsylvania, 15009, United States

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Bensalem, Pennsylvania, 19020, United States

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Hershey, Pennsylvania, 17033, United States

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Norristown, Pennsylvania, 19401, United States

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Greer, South Carolina, 29651, United States

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Clarksville, Tennessee, 37043, United States

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Kingsport, Tennessee, 37660, United States

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Arlington, Texas, 76014, United States

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Dallas, Texas, 75251, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77030, United States

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Lewisville, Texas, 75067, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78229, United States

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St. George, Utah, 84790, United States

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Arlington, Virginia, 22204, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23249, United States

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Warrenton, Virginia, 20186, United States

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Tacoma, Washington, 98405, United States

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Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 15, 2006
• Study Start: November 29, 2006
• Primary Completion: March 18, 2008
• Study Completion: March 18, 2008
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

US (110)