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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: February 28, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • Fasting plasma glucose [ Time Frame: after 26 weeks of treatment ]
  • Lipid profiles [ Time Frame: after 26 weeks of treatment ]
  • Frequency of hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ]
  • Glucose profiles [ Time Frame: at pre- and post meals, bedtime and 3:00 am ]
  • Change in body weight [ Time Frame: after 26 weeks of treatment ]

Enrollment: 196
Actual Study Start Date: November 29, 2006
Study Completion Date: March 18, 2008
Primary Completion Date: March 18, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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, Alabama
Novo Nordisk Investigational Site
Ozark, Alabama, United States, 36360
Novo Nordisk Investigational Site
Tuscaloosa, Alabama, United States, 35406
Novo Nordisk Investigational Site
Vestavia, Alabama, United States, 35209
United States, Arizona
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85741
United States, Arkansas
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72204
United States, California
Novo Nordisk Investigational Site
Bermuda Dunes,, California, United States, 92203
Novo Nordisk Investigational Site
Escondido, California, United States, 92025
Novo Nordisk Investigational Site
Fresno, California, United States, 93720
Novo Nordisk Investigational Site
Huntington Beach, California, United States, 92646
Novo Nordisk Investigational Site
La Jolla, California, United States, 92037
Novo Nordisk Investigational Site
Northridge, California, United States, 91325
Novo Nordisk Investigational Site
Orange, California, United States, 92868
Novo Nordisk Investigational Site
Orange, California, United States, 92869
Novo Nordisk Investigational Site
Poway, California, United States, 92064
Novo Nordisk Investigational Site
Roseville, California, United States, 95661
Novo Nordisk Investigational Site
Sacramento, California, United States, 95821
Novo Nordisk Investigational Site
San Diego, California, United States, 92103-620
Novo Nordisk Investigational Site
Santa Barbara, California, United States, 93105
Novo Nordisk Investigational Site
Temecula, California, United States, 92591
Novo Nordisk Investigational Site
Tustin, California, United States, 92780
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
Novo Nordisk Investigational Site
Arvada, Colorado, United States, 80005
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80904
United States, Florida
Novo Nordisk Investigational Site
Beverly Hills, Florida, United States, 34465
Novo Nordisk Investigational Site
Boca Raton, Florida, United States, 33433
Novo Nordisk Investigational Site
Clearwater, Florida, United States, 33759
Novo Nordisk Investigational Site
Hialead, Florida, United States, 33010
Novo Nordisk Investigational Site
Hollywood, Florida, United States, 33021
Novo Nordisk Investigational Site
Lake Mary, Florida, United States, 32746
Novo Nordisk Investigational Site
Marianna, Florida, United States, 32446
Novo Nordisk Investigational Site
Melbourne, Florida, United States, 32901
Novo Nordisk Investigational Site
Miami, Florida, United States, 33136
Novo Nordisk Investigational Site
Niceville, Florida, United States, 32578
Novo Nordisk Investigational Site
Palm Harbor, Florida, United States, 34684
Novo Nordisk Investigational Site
Panama City, Florida, United States, 32401
Novo Nordisk Investigational Site
Pembroke Pines, Florida, United States, 33029
Novo Nordisk Investigational Site
St. Petersburg, Florida, United States, 33709
Novo Nordisk Investigational Site
Tallahassee, Florida, United States, 32308
Novo Nordisk Investigational Site
Vero Beach, Florida, United States, 32960
Novo Nordisk Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Novo Nordisk Investigational Site
Athens, Georgia, United States, 30606
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30342
Novo Nordisk Investigational Site
Blue Ridge, Georgia, United States, 30513
Novo Nordisk Investigational Site
Dunwoody, Georgia, United States, 30338
Novo Nordisk Investigational Site
Powder Springs, Georgia, United States, 30127
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
Novo Nordisk Investigational Site
Sandy Springs, Georgia, United States, 30328
Novo Nordisk Investigational Site
Suwanee, Georgia, United States, 30024
Novo Nordisk Investigational Site
Tucker, Georgia, United States, 30084
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Idaho
Novo Nordisk Investigational Site
Boise, Idaho, United States, 83702
United States, Illinois
Novo Nordisk Investigational Site
Avon, Illinois, United States, 46123
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60611
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60612
Novo Nordisk Investigational Site
Peoria, Illinois, United States, 61615
United States, Indiana
Novo Nordisk Investigational Site
Lafayette, Indiana, United States, 47904
United States, Iowa
Novo Nordisk Investigational Site
Des Moines, Iowa, United States, 50314
United States, Kansas
Novo Nordisk Investigational Site
Topeka, Kansas, United States, 66606
Novo Nordisk Investigational Site
Wichita, Kansas, United States, 67205
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21201
Novo Nordisk Investigational Site
Prince Frederick, Maryland, United States, 20678
United States, Massachusetts
Novo Nordisk Investigational Site
Marlborough, Massachusetts, United States, 01752
Novo Nordisk Investigational Site
Waltham, Massachusetts, United States, 02453
United States, Minnesota
Novo Nordisk Investigational Site
Bloomington, Minnesota, United States, 55420
United States, Mississippi
Novo Nordisk Investigational Site
Jackson, Mississippi, United States, 39216
United States, Missouri
Novo Nordisk Investigational Site
Chesterfield, Missouri, United States, 63017
Novo Nordisk Investigational Site
Jefferson City, Missouri, United States, 65109
Novo Nordisk Investigational Site
Kansas City, Missouri, United States, 64111
Novo Nordisk Investigational Site
St. Louis, Missouri, United States, 63141
United States, Montana
Novo Nordisk Investigational Site
Billings, Montana, United States, 59102
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89109
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New York
Novo Nordisk Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States, 28209
Novo Nordisk Investigational Site
High Point, North Carolina, United States, 27262
Novo Nordisk Investigational Site
Raleigh, North Carolina, United States, 27612
Novo Nordisk Investigational Site
Winston Salem, North Carolina, United States, 27103
United States, North Dakota
Novo Nordisk Investigational Site
Bismarck, North Dakota, United States, 58501
United States, Ohio
Novo Nordisk Investigational Site
Canal Fulton, Ohio, United States, 44614
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45224
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45245
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44115
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44122
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45439
United States, Oklahoma
Novo Nordisk Investigational Site
Clinton, Oklahoma, United States, 73601
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104-5020
United States, Oregon
Novo Nordisk Investigational Site
Medford, Oregon, United States, 97504-8491
United States, Pennsylvania
Novo Nordisk Investigational Site
Altoona, Pennsylvania, United States, 16602
Novo Nordisk Investigational Site
Beaver, Pennsylvania, United States, 15009
Novo Nordisk Investigational Site
Bensalem, Pennsylvania, United States, 19020
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Investigational Site
Norristown, Pennsylvania, United States, 19401
United States, South Carolina
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Novo Nordisk Investigational Site
Clarksville, Tennessee, United States, 37043
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Investigational Site
Arlington, Texas, United States, 76014
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75251
Novo Nordisk Investigational Site
Houston, Texas, United States, 77024
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Novo Nordisk Investigational Site
Lewisville, Texas, United States, 75067
Novo Nordisk Investigational Site
Plano, Texas, United States, 75093
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Novo Nordisk Investigational Site
St. George, Utah, United States, 84790
United States, Virginia
Novo Nordisk Investigational Site
Arlington, Virginia, United States, 22204
Novo Nordisk Investigational Site
Norfolk, Virginia, United States, 23502
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23249
Novo Nordisk Investigational Site
Warrenton, Virginia, United States, 20186
United States, Washington
Novo Nordisk Investigational Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
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: February 28, 2017

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

ClinicalTrials.gov processed this record on May 23, 2017