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

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00411892
First received: December 14, 2006
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: pioglitazone
Drug: inhaled human insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c change from baseline [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Lipid profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Frequency of hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Glucose profiles [ Time Frame: at pre- and post meals, bedtime and 3:00 am ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: November 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: pioglitazone
Tablets, 45 mg/day.
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Other Name: NN1998
Active Comparator: B Drug: pioglitazone
Tablets, 45 mg/day.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411892

  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Tucson, Arizona, United States, 85741
United States, Arkansas
Novo Nordisk Clinical Trial Call Center
Little Rock, Arkansas, United States, 72204
United States, California
Novo Nordisk Clinical Trial Call Center
Carmichael, California, United States, 95608
Novo Nordisk Clinical Trial Call Center
Escondido, California, United States, 92026
Novo Nordisk Clinical Trial Call Center
Fresno, California, United States, 93720
Novo Nordisk Clinical Trial Call Center
Huntington Beach, California, United States, 92646
Novo Nordisk Clinical Trial Call Center
La Jolla, California, United States, 92037
Novo Nordisk Clinical Trial Call Center
Northridge, California, United States, 91325
Novo Nordisk Clinical Trial Call Center
Orange, California, United States, 92868
Novo Nordisk Clinical Trial Call Center
Orange, California, United States, 92869
Novo Nordisk Clinical Trial Call Center
Palm Springs, California, United States, 92262
Novo Nordisk Clinical Trial Call Center
Poway, California, United States, 92064
Novo Nordisk Clinical Trial Call Center
Roseville, California, United States, 95661
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92103
Novo Nordisk Clinical Trial Call Center
Santa Barbara, California, United States, 93105
Novo Nordisk Clinical Trial Call Center
Tustin, California, United States, 92780
Novo Nordisk Clinical Trial Call Center
Walnut Creek, California, United States, 94598
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Arvada, Colorado, United States, 80005
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, United States, 80904
United States, Florida
Novo Nordisk Clinical Trial Call Center
Hialead, Florida, United States, 33010
Novo Nordisk Clinical Trial Call Center
Hollywood, Florida, United States, 33021
Novo Nordisk Clinical Trial Call Center
Lake Mary, Florida, United States, 32746
Novo Nordisk Clinical Trial Call Center
Melbourne, Florida, United States, 32901
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33136
Novo Nordisk Clinical Trial Call Center
Niceville, Florida, United States, 32578
Novo Nordisk Clinical Trial Call Center
Palm Harbor, Florida, United States, 34684
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Panama City, Florida, United States, 32401
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Pembroke Pines, Florida, United States, 33029
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Tallahassee, Florida, United States, 32308
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Vero Beach, Florida, United States, 32960
Novo Nordisk Clinical Trial Call Center
West Palm Beach, Florida, United States, 33401
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Athens, Georgia, United States, 30606
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30342
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Blue Ridge, Georgia, United States, 30513
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Dunwoody, Georgia, United States, 30338
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Roswell, Georgia, United States, 30076
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Sandy Springs, Georgia, United States, 30328
Novo Nordisk Clinical Trial Call Center
Suwanee, Georgia, United States, 30024
Novo Nordisk Clinical Trial Call Center
Tucker, Georgia, United States, 30084
United States, Hawaii
Novo Nordisk Clinical Trial Call Center
Honolulu, Hawaii, United States, 96814
United States, Idaho
Novo Nordisk Clinical Trial Call Center
Boise, Idaho, United States, 83702
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60607
Novo Nordisk Clinical Trial Call Center
Peoria, Illinois, United States, 61615
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Des Moines, Iowa, United States, 50314
United States, Kansas
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Topeka, Kansas, United States, 66606
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Wichita, Kansas, United States, 67207
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Lexington, Kentucky, United States, 40503
United States, Maryland
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Baltimore, Maryland, United States, 21201
Novo Nordisk Clinical Trial Call Center
Prince Frederick, Maryland, United States, 20678
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Bloomington, Minnesota, United States, 55420
United States, Mississippi
Novo Nordisk Clinical Trial Call Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Chesterfield, Missouri, United States, 63017
Novo Nordisk Clinical Trial Call Center
Jefferson City, Missouri, United States, 65109-6001
Novo Nordisk Clinical Trial Call Center
Kansas City, Missouri, United States, 64111
Novo Nordisk Clinical Trial Call Center
St. Louis, Missouri, United States, 63141
United States, Montana
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Billings, Montana, United States, 59102
United States, Nevada
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Las Vegas, Nevada, United States, 89128
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Charlotte, North Carolina, United States, 28209
Novo Nordisk Clinical Trial Call Center
High Point, North Carolina, United States, 27262
Novo Nordisk Clinical Trial Call Center
Raleigh, North Carolina, United States, 27612
Novo Nordisk Clinical Trial Call Center
Winston Salem, North Carolina, United States, 27103
United States, North Dakota
Novo Nordisk Clinical Trial Call Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Canal Fulton, Ohio, United States, 44614
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45224
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45245
Novo Nordisk Clinical Trial Call Center
Cleveland, Ohio, United States, 44122
Novo Nordisk Clinical Trial Call Center
Cleveland, Ohio, United States, 44115
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45439
United States, Oklahoma
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Clinton, Oklahoma, United States, 73601
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Oklahoma City, Oklahoma, United States, 73104-5020
United States, Oregon
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Medford, Oregon, United States, 97504
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Beaver, Pennsylvania, United States, 15009
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Bensalem, Pennsylvania, United States, 19020
Novo Nordisk Clinical Trial Call Center
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Clinical Trial Call Center
Norristown, Pennsylvania, United States, 19401
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Greer, South Carolina, United States, 29651
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Clinical Trial Call Center
Arlington, Texas, United States, 76014
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75251
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77024
Novo Nordisk Clinical Trial Call Center
Lewisville, Texas, United States, 75067
Novo Nordisk Clinical Trial Call Center
Plano, Texas, United States, 75093
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229
United States, Utah
Novo Nordisk Clinical Trial Call Center
St. George, Utah, United States, 84790
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Warrenton, Virginia, United States, 20186
United States, Washington
Novo Nordisk Clinical Trial Call Center
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Theresa Brennan Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00411892     History of Changes
Other Study ID Numbers: NN1998-1683
Study First Received: December 14, 2006
Last Updated: July 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014