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

September 3, 2018 updated by: Novo Nordisk A/S

Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride on HbA1c in Subjects With Type 2 Diabetes

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hueytown, Alabama, United States, 35023
        • Novo Nordisk Investigational Site
      • Ozark, Alabama, United States, 36360
        • Novo Nordisk Investigational Site
      • Tuscaloosa, Alabama, United States, 35406
        • Novo Nordisk Investigational Site
      • Vestavia Hills, Alabama, United States, 35209
        • Novo Nordisk Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Novo Nordisk Investigational Site
    • California
      • Concord, California, United States, 94520
        • 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
      • 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
        • Novo Nordisk Investigational Site
      • Santa Barbara, California, United States, 93105
        • Novo Nordisk Investigational Site
      • Temecula, California, United States, 92591
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Novo Nordisk Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Novo Nordisk Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33433
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, United States, 33759
        • Novo Nordisk Investigational Site
      • Hialeah, 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
      • Merritt Island, Florida, United States, 32953
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33136
        • Novo Nordisk Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33029
        • Novo Nordisk Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Novo Nordisk Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Novo Nordisk Investigational Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30342
        • Novo Nordisk Investigational Site
      • Augusta, Georgia, United States, 30912-3152
        • 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
      • Suwanee, Georgia, United States, 30024
        • Novo Nordisk Investigational Site
      • Tucker, Georgia, United States, 30084
        • Novo Nordisk Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novo Nordisk Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Peoria, Illinois, United States, 61615
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
    • Indiana
      • Lafayette, Indiana, United States, 47904
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Novo Nordisk Investigational Site
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Novo Nordisk Investigational Site
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
      • Wichita, Kansas, United States, 67205
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
    • Maine
      • Scarborough, Maine, United States, 04074
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Marlborough, Massachusetts, United States, 01752
        • Novo Nordisk Investigational Site
      • Springfield, Massachusetts, United States, 01199
        • Novo Nordisk Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Novo Nordisk Investigational Site
    • Missouri
      • 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
      • Saint Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
      • Cherry Hill, New Jersey, United States, 08034
        • Novo Nordisk Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
    • New York
      • Staten Island, New York, United States, 10301
        • Novo Nordisk Investigational Site
      • Syracuse, New York, United States, 13210
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Novo Nordisk Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • Novo Nordisk Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
      • High Point, North Carolina, United States, 27262
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44115
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45406
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Clinton, Oklahoma, United States, 73601
        • Novo Nordisk Investigational Site
      • Oklahoma City, Oklahoma, United States, 73104-5020
        • Novo Nordisk Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504-8491
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Beaver, Pennsylvania, United States, 15009
        • Novo Nordisk Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
      • Clarksville, Tennessee, United States, 37043
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
      • Hurst, Texas, United States, 76054
        • Novo Nordisk Investigational Site
      • Lewisville, Texas, United States, 75067
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
    • Virginia
      • 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
        • Novo Nordisk Investigational Site
    • Washington
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
      • Tacoma, Washington, United States, 98405
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Other Names:
  • NN1998
Drug: metformin
Tablets, 2000 mg/day.
Drug: glimepiride
Tablets, 8 mg/day.
Active Comparator: B
Drug: metformin
Tablets, 2000 mg/day.
Drug: glimepiride
Tablets, 8 mg/day.
Drug: rosiglitazone
Tablets, 4 mg once or twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: After 26 weeks
After 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting plasma glucose
Time Frame: For the duration of the trial
For the duration of the trial
Lipid profiles
Time Frame: For the duration of the trial
For the duration of the trial
Hypoglycaemic episodes
Time Frame: For the duration of the trial
For the duration of the trial
Glucose profiles
Time Frame: For the duration of the trial
For the duration of the trial
Change in body weight
Time Frame: For the duration of the trial
For the duration of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2007

Primary Completion (Actual)

March 11, 2008

Study Completion (Actual)

March 11, 2008

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (Estimate)

January 26, 2007

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1998-1540

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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