Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT00427154
Collaborator
(none)
227
103
2
14
2.2
0.2
Study Details
Study Description
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 or rosiglitazone treatment, both in combination with metformin and glimepiride.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Study Type:
Interventional
Actual Enrollment
:
227 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride on HbA1c in Subjects With Type 2 Diabetes
Actual Study Start Date
:
Jan 10, 2007
Actual Primary Completion Date
:
Mar 11, 2008
Actual Study Completion Date
:
Mar 11, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A
|
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Other Names:
Drug: metformin
Tablets, 2000 mg/day.
Drug: glimepiride
Tablets, 8 mg/day.
|
| Active Comparator: B
|
Drug: rosiglitazone
Tablets, 4 mg once or twice daily.
Drug: metformin
Tablets, 2000 mg/day.
Drug: glimepiride
Tablets, 8 mg/day.
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c [After 26 weeks]
Secondary Outcome Measures
- Fasting plasma glucose [For the duration of the trial]
- Lipid profiles [For the duration of the trial]
- Hypoglycaemic episodes [For the duration of the trial]
- Glucose profiles [For the duration of the trial]
- Change in body weight [For the duration of the trial]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Hueytown | Alabama | United States | 35023 |
| 2 | Novo Nordisk Investigational Site | Ozark | Alabama | United States | 36360 |
| 3 | Novo Nordisk Investigational Site | Tuscaloosa | Alabama | United States | 35406 |
| 4 | Novo Nordisk Investigational Site | Vestavia Hills | Alabama | United States | 35209 |
| 5 | Novo Nordisk Investigational Site | Tucson | Arizona | United States | 85741 |
| 6 | Novo Nordisk Investigational Site | Concord | California | United States | 94520 |
| 7 | Novo Nordisk Investigational Site | Escondido | California | United States | 92025 |
| 8 | Novo Nordisk Investigational Site | Fresno | California | United States | 93720 |
| 9 | Novo Nordisk Investigational Site | Huntington Beach | California | United States | 92646 |
| 10 | Novo Nordisk Investigational Site | La Jolla | California | United States | 92037 |
| 11 | Novo Nordisk Investigational Site | Orange | California | United States | 92869 |
| 12 | Novo Nordisk Investigational Site | Poway | California | United States | 92064 |
| 13 | Novo Nordisk Investigational Site | Roseville | California | United States | 95661 |
| 14 | Novo Nordisk Investigational Site | Sacramento | California | United States | 95821 |
| 15 | Novo Nordisk Investigational Site | San Diego | California | United States | 92103 |
| 16 | Novo Nordisk Investigational Site | Santa Barbara | California | United States | 93105 |
| 17 | Novo Nordisk Investigational Site | Temecula | California | United States | 92591 |
| 18 | Novo Nordisk Investigational Site | Walnut Creek | California | United States | 94598 |
| 19 | Novo Nordisk Investigational Site | Colorado Springs | Colorado | United States | 80904 |
| 20 | Novo Nordisk Investigational Site | Waterbury | Connecticut | United States | 06708 |
| 21 | Novo Nordisk Investigational Site | Boca Raton | Florida | United States | 33433 |
| 22 | Novo Nordisk Investigational Site | Clearwater | Florida | United States | 33759 |
| 23 | Novo Nordisk Investigational Site | Hialeah | Florida | United States | 33010 |
| 24 | Novo Nordisk Investigational Site | Hollywood | Florida | United States | 33021 |
| 25 | Novo Nordisk Investigational Site | Lake Mary | Florida | United States | 32746 |
| 26 | Novo Nordisk Investigational Site | Marianna | Florida | United States | 32446 |
| 27 | Novo Nordisk Investigational Site | Melbourne | Florida | United States | 32901 |
| 28 | Novo Nordisk Investigational Site | Merritt Island | Florida | United States | 32953 |
| 29 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33136 |
| 30 | Novo Nordisk Investigational Site | Palm Harbor | Florida | United States | 34684 |
| 31 | Novo Nordisk Investigational Site | Pembroke Pines | Florida | United States | 33029 |
| 32 | Novo Nordisk Investigational Site | Vero Beach | Florida | United States | 32960 |
| 33 | Novo Nordisk Investigational Site | West Palm Beach | Florida | United States | 33401 |
| 34 | Novo Nordisk Investigational Site | Athens | Georgia | United States | 30606 |
| 35 | Novo Nordisk Investigational Site | Atlanta | Georgia | United States | 30318 |
| 36 | Novo Nordisk Investigational Site | Atlanta | Georgia | United States | 30342 |
| 37 | Novo Nordisk Investigational Site | Augusta | Georgia | United States | 30912-3152 |
| 38 | Novo Nordisk Investigational Site | Dunwoody | Georgia | United States | 30338 |
| 39 | Novo Nordisk Investigational Site | Powder Springs | Georgia | United States | 30127 |
| 40 | Novo Nordisk Investigational Site | Roswell | Georgia | United States | 30076 |
| 41 | Novo Nordisk Investigational Site | Suwanee | Georgia | United States | 30024 |
| 42 | Novo Nordisk Investigational Site | Tucker | Georgia | United States | 30084 |
| 43 | Novo Nordisk Investigational Site | Honolulu | Hawaii | United States | 96814 |
| 44 | Novo Nordisk Investigational Site | Boise | Idaho | United States | 83702 |
| 45 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60607 |
| 46 | Novo Nordisk Investigational Site | Peoria | Illinois | United States | 61615 |
| 47 | Novo Nordisk Investigational Site | Springfield | Illinois | United States | 62711 |
| 48 | Novo Nordisk Investigational Site | Lafayette | Indiana | United States | 47904 |
| 49 | Novo Nordisk Investigational Site | Des Moines | Iowa | United States | 50314 |
| 50 | Novo Nordisk Investigational Site | Shawnee Mission | Kansas | United States | 66204 |
| 51 | Novo Nordisk Investigational Site | Topeka | Kansas | United States | 66606 |
| 52 | Novo Nordisk Investigational Site | Wichita | Kansas | United States | 67205 |
| 53 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40503 |
| 54 | Novo Nordisk Investigational Site | Scarborough | Maine | United States | 04074 |
| 55 | Novo Nordisk Investigational Site | Baltimore | Maryland | United States | 21201 |
| 56 | Novo Nordisk Investigational Site | Marlborough | Massachusetts | United States | 01752 |
| 57 | Novo Nordisk Investigational Site | Springfield | Massachusetts | United States | 01199 |
| 58 | Novo Nordisk Investigational Site | Jackson | Mississippi | United States | 39216 |
| 59 | Novo Nordisk Investigational Site | Chesterfield | Missouri | United States | 63017 |
| 60 | Novo Nordisk Investigational Site | Jefferson City | Missouri | United States | 65109 |
| 61 | Novo Nordisk Investigational Site | Kansas City | Missouri | United States | 64111 |
| 62 | Novo Nordisk Investigational Site | Saint Louis | Missouri | United States | 63141 |
| 63 | Novo Nordisk Investigational Site | Billings | Montana | United States | 59101 |
| 64 | Novo Nordisk Investigational Site | Omaha | Nebraska | United States | 68114 |
| 65 | Novo Nordisk Investigational Site | Las Vegas | Nevada | United States | 89109 |
| 66 | Novo Nordisk Investigational Site | Berlin | New Jersey | United States | 08009 |
| 67 | Novo Nordisk Investigational Site | Cherry Hill | New Jersey | United States | 08034 |
| 68 | Novo Nordisk Investigational Site | Lawrenceville | New Jersey | United States | 08648 |
| 69 | Novo Nordisk Investigational Site | Staten Island | New York | United States | 10301 |
| 70 | Novo Nordisk Investigational Site | Syracuse | New York | United States | 13210 |
| 71 | Novo Nordisk Investigational Site | Asheville | North Carolina | United States | 28803 |
| 72 | Novo Nordisk Investigational Site | Charlotte | North Carolina | United States | 28209 |
| 73 | Novo Nordisk Investigational Site | Greenville | North Carolina | United States | 27834 |
| 74 | Novo Nordisk Investigational Site | High Point | North Carolina | United States | 27262 |
| 75 | Novo Nordisk Investigational Site | Cincinnati | Ohio | United States | 45245 |
| 76 | Novo Nordisk Investigational Site | Cleveland | Ohio | United States | 44115 |
| 77 | Novo Nordisk Investigational Site | Cleveland | Ohio | United States | 44122 |
| 78 | Novo Nordisk Investigational Site | Dayton | Ohio | United States | 45406 |
| 79 | Novo Nordisk Investigational Site | Dayton | Ohio | United States | 45439 |
| 80 | Novo Nordisk Investigational Site | Clinton | Oklahoma | United States | 73601 |
| 81 | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | United States | 73104-5020 |
| 82 | Novo Nordisk Investigational Site | Medford | Oregon | United States | 97504-8491 |
| 83 | Novo Nordisk Investigational Site | Altoona | Pennsylvania | United States | 16602 |
| 84 | Novo Nordisk Investigational Site | Beaver | Pennsylvania | United States | 15009 |
| 85 | Novo Nordisk Investigational Site | Norristown | Pennsylvania | United States | 19401 |
| 86 | Novo Nordisk Investigational Site | Greer | South Carolina | United States | 29651 |
| 87 | Novo Nordisk Investigational Site | Chattanooga | Tennessee | United States | 37404 |
| 88 | Novo Nordisk Investigational Site | Chattanooga | Tennessee | United States | 37411 |
| 89 | Novo Nordisk Investigational Site | Clarksville | Tennessee | United States | 37043 |
| 90 | Novo Nordisk Investigational Site | Kingsport | Tennessee | United States | 37660 |
| 91 | Novo Nordisk Investigational Site | Arlington | Texas | United States | 76014 |
| 92 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75230 |
| 93 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75231 |
| 94 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77030 |
| 95 | Novo Nordisk Investigational Site | Hurst | Texas | United States | 76054 |
| 96 | Novo Nordisk Investigational Site | Lewisville | Texas | United States | 75067 |
| 97 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78229 |
| 98 | Novo Nordisk Investigational Site | Arlington | Virginia | United States | 22204 |
| 99 | Novo Nordisk Investigational Site | Norfolk | Virginia | United States | 23502 |
| 100 | Novo Nordisk Investigational Site | Richmond | Virginia | United States | 23249 |
| 101 | Novo Nordisk Investigational Site | Warrenton | Virginia | United States | 20186 |
| 102 | Novo Nordisk Investigational Site | Renton | Washington | United States | 98057 |
| 103 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00427154
Other Study ID Numbers:
- NN1998-1540
First Posted:
Jan 26, 2007
Last Update Posted:
Sep 5, 2018
Last Verified:
Sep 1, 2018
Additional relevant MeSH terms: