Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT00411892
Collaborator
(none)
196
110
2
15.6
1.8
0.1
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 and pioglitazone combination therapy versus pioglitazone treatment alone.
| 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
:
196 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Actual Study Start Date
:
Nov 29, 2006
Actual Primary Completion Date
:
Mar 18, 2008
Actual Study Completion Date
:
Mar 18, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A
|
Drug: pioglitazone
Tablets, 45 mg/day.
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Other Names:
|
| Active Comparator: B
|
Drug: pioglitazone
Tablets, 45 mg/day.
|
Outcome Measures
Primary Outcome Measures
- HbA1c change from baseline [After 26 weeks of treatment]
Secondary Outcome Measures
- 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]
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
-
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Ozark | Alabama | United States | 36360 |
| 2 | Novo Nordisk Investigational Site | Tuscaloosa | Alabama | United States | 35406 |
| 3 | Novo Nordisk Investigational Site | Vestavia Hills | Alabama | United States | 35209 |
| 4 | Novo Nordisk Investigational Site | Tucson | Arizona | United States | 85741 |
| 5 | Novo Nordisk Investigational Site | Little Rock | Arkansas | United States | 72204 |
| 6 | Novo Nordisk Investigational Site | Bermuda Dunes | California | United States | 92203 |
| 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 | Northridge | California | United States | 91325 |
| 12 | Novo Nordisk Investigational Site | Orange | California | United States | 92868 |
| 13 | Novo Nordisk Investigational Site | Orange | California | United States | 92869 |
| 14 | Novo Nordisk Investigational Site | Poway | California | United States | 92064 |
| 15 | Novo Nordisk Investigational Site | Roseville | California | United States | 95661 |
| 16 | Novo Nordisk Investigational Site | Sacramento | California | United States | 95821 |
| 17 | Novo Nordisk Investigational Site | San Diego | California | United States | 92103-620 |
| 18 | Novo Nordisk Investigational Site | Santa Barbara | California | United States | 93105 |
| 19 | Novo Nordisk Investigational Site | Temecula | California | United States | 92591 |
| 20 | Novo Nordisk Investigational Site | Tustin | California | United States | 92780 |
| 21 | Novo Nordisk Investigational Site | Walnut Creek | California | United States | 94598 |
| 22 | Novo Nordisk Investigational Site | Arvada | Colorado | United States | 80005 |
| 23 | Novo Nordisk Investigational Site | Colorado Springs | Colorado | United States | 80904 |
| 24 | Novo Nordisk Investigational Site | Beverly Hills | Florida | United States | 34465 |
| 25 | Novo Nordisk Investigational Site | Boca Raton | Florida | United States | 33433 |
| 26 | Novo Nordisk Investigational Site | Clearwater | Florida | United States | 33759 |
| 27 | Novo Nordisk Investigational Site | Hialeah | Florida | United States | 33010 |
| 28 | Novo Nordisk Investigational Site | Hollywood | Florida | United States | 33021 |
| 29 | Novo Nordisk Investigational Site | Lake Mary | Florida | United States | 32746 |
| 30 | Novo Nordisk Investigational Site | Marianna | Florida | United States | 32446 |
| 31 | Novo Nordisk Investigational Site | Melbourne | Florida | United States | 32901 |
| 32 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33136 |
| 33 | Novo Nordisk Investigational Site | Niceville | Florida | United States | 32578 |
| 34 | Novo Nordisk Investigational Site | Palm Harbor | Florida | United States | 34684 |
| 35 | Novo Nordisk Investigational Site | Panama City | Florida | United States | 32401 |
| 36 | Novo Nordisk Investigational Site | Pembroke Pines | Florida | United States | 33029 |
| 37 | Novo Nordisk Investigational Site | Saint Petersburg | Florida | United States | 33709 |
| 38 | Novo Nordisk Investigational Site | Tallahassee | Florida | United States | 32308 |
| 39 | Novo Nordisk Investigational Site | Vero Beach | Florida | United States | 32960 |
| 40 | Novo Nordisk Investigational Site | West Palm Beach | Florida | United States | 33401 |
| 41 | Novo Nordisk Investigational Site | Athens | Georgia | United States | 30606 |
| 42 | Novo Nordisk Investigational Site | Atlanta | Georgia | United States | 30342 |
| 43 | Novo Nordisk Investigational Site | Blue Ridge | Georgia | United States | 30513 |
| 44 | Novo Nordisk Investigational Site | Dunwoody | Georgia | United States | 30338 |
| 45 | Novo Nordisk Investigational Site | Powder Springs | Georgia | United States | 30127 |
| 46 | Novo Nordisk Investigational Site | Roswell | Georgia | United States | 30076 |
| 47 | Novo Nordisk Investigational Site | Sandy Springs | Georgia | United States | 30328 |
| 48 | Novo Nordisk Investigational Site | Suwanee | Georgia | United States | 30024 |
| 49 | Novo Nordisk Investigational Site | Tucker | Georgia | United States | 30084 |
| 50 | Novo Nordisk Investigational Site | Honolulu | Hawaii | United States | 96814 |
| 51 | Novo Nordisk Investigational Site | Boise | Idaho | United States | 83702 |
| 52 | Novo Nordisk Investigational Site | Avon | Illinois | United States | 46123 |
| 53 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60607 |
| 54 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60611 |
| 55 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60612 |
| 56 | Novo Nordisk Investigational Site | Peoria | Illinois | United States | 61615 |
| 57 | Novo Nordisk Investigational Site | Lafayette | Indiana | United States | 47904 |
| 58 | Novo Nordisk Investigational Site | Des Moines | Iowa | United States | 50314 |
| 59 | Novo Nordisk Investigational Site | Topeka | Kansas | United States | 66606 |
| 60 | Novo Nordisk Investigational Site | Wichita | Kansas | United States | 67205 |
| 61 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40503 |
| 62 | Novo Nordisk Investigational Site | Baltimore | Maryland | United States | 21201 |
| 63 | Novo Nordisk Investigational Site | Prince Frederick | Maryland | United States | 20678 |
| 64 | Novo Nordisk Investigational Site | Marlborough | Massachusetts | United States | 01752 |
| 65 | Novo Nordisk Investigational Site | Waltham | Massachusetts | United States | 02453 |
| 66 | Novo Nordisk Investigational Site | Bloomington | Minnesota | United States | 55420 |
| 67 | Novo Nordisk Investigational Site | Jackson | Mississippi | United States | 39216 |
| 68 | Novo Nordisk Investigational Site | Chesterfield | Missouri | United States | 63017 |
| 69 | Novo Nordisk Investigational Site | Jefferson City | Missouri | United States | 65109 |
| 70 | Novo Nordisk Investigational Site | Kansas City | Missouri | United States | 64111 |
| 71 | Novo Nordisk Investigational Site | Saint Louis | Missouri | United States | 63141 |
| 72 | Novo Nordisk Investigational Site | Billings | Montana | United States | 59102 |
| 73 | Novo Nordisk Investigational Site | Las Vegas | Nevada | United States | 89109 |
| 74 | Novo Nordisk Investigational Site | Las Vegas | Nevada | United States | 89128 |
| 75 | Novo Nordisk Investigational Site | Syracuse | New York | United States | 13210 |
| 76 | Novo Nordisk Investigational Site | Charlotte | North Carolina | United States | 28209 |
| 77 | Novo Nordisk Investigational Site | High Point | North Carolina | United States | 27262 |
| 78 | Novo Nordisk Investigational Site | Raleigh | North Carolina | United States | 27612 |
| 79 | Novo Nordisk Investigational Site | Winston-Salem | North Carolina | United States | 27103 |
| 80 | Novo Nordisk Investigational Site | Bismarck | North Dakota | United States | 58501 |
| 81 | Novo Nordisk Investigational Site | Canal Fulton | Ohio | United States | 44614 |
| 82 | Novo Nordisk Investigational Site | Cincinnati | Ohio | United States | 45224 |
| 83 | Novo Nordisk Investigational Site | Cincinnati | Ohio | United States | 45245 |
| 84 | Novo Nordisk Investigational Site | Cleveland | Ohio | United States | 44115 |
| 85 | Novo Nordisk Investigational Site | Cleveland | Ohio | United States | 44122 |
| 86 | Novo Nordisk Investigational Site | Dayton | Ohio | United States | 45439 |
| 87 | Novo Nordisk Investigational Site | Clinton | Oklahoma | United States | 73601 |
| 88 | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | United States | 73104-5020 |
| 89 | Novo Nordisk Investigational Site | Medford | Oregon | United States | 97504-8491 |
| 90 | Novo Nordisk Investigational Site | Altoona | Pennsylvania | United States | 16602 |
| 91 | Novo Nordisk Investigational Site | Beaver | Pennsylvania | United States | 15009 |
| 92 | Novo Nordisk Investigational Site | Bensalem | Pennsylvania | United States | 19020 |
| 93 | Novo Nordisk Investigational Site | Hershey | Pennsylvania | United States | 17033 |
| 94 | Novo Nordisk Investigational Site | Norristown | Pennsylvania | United States | 19401 |
| 95 | Novo Nordisk Investigational Site | Greer | South Carolina | United States | 29651 |
| 96 | Novo Nordisk Investigational Site | Clarksville | Tennessee | United States | 37043 |
| 97 | Novo Nordisk Investigational Site | Kingsport | Tennessee | United States | 37660 |
| 98 | Novo Nordisk Investigational Site | Arlington | Texas | United States | 76014 |
| 99 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75251 |
| 100 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77024 |
| 101 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77030 |
| 102 | Novo Nordisk Investigational Site | Lewisville | Texas | United States | 75067 |
| 103 | Novo Nordisk Investigational Site | Plano | Texas | United States | 75093 |
| 104 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78229 |
| 105 | Novo Nordisk Investigational Site | Saint George | Utah | United States | 84790 |
| 106 | Novo Nordisk Investigational Site | Arlington | Virginia | United States | 22204 |
| 107 | Novo Nordisk Investigational Site | Norfolk | Virginia | United States | 23502 |
| 108 | Novo Nordisk Investigational Site | Richmond | Virginia | United States | 23249 |
| 109 | Novo Nordisk Investigational Site | Warrenton | Virginia | United States | 20186 |
| 110 | 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:
NCT00411892
Other Study ID Numbers:
- NN1998-1683
First Posted:
Dec 15, 2006
Last Update Posted:
Sep 5, 2018
Last Verified:
Sep 1, 2018
Additional relevant MeSH terms: