Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge
Sponsor
Mannkind Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00642681
Collaborator
(none)
20
24
8
0.8
0.1
Study Details
Study Description
Brief Summary
Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Effect of Symptomatic Upper Respiratory Infections on Pharmacological Characteristics of Technosphere®/Insulin in Subjects With Diabetes Mellitus After a Meal Challenge
Study Start Date
:
Dec 1, 2007
Actual Primary Completion Date
:
Jul 1, 2008
Actual Study Completion Date
:
Aug 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1: TI Inhalation Powder Technosphere® Insulin (TI) Inhalation Powder |
Drug: Technosphere Insulin
Technosphere® Insulin (TI) Inhalation Powder, prandial
|
Outcome Measures
Primary Outcome Measures
- To measure Serum FDKP AUC [4 Hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects will have met the same inclusion criteria as MKC-TI-030
-
Clinical diagnosis of URI with in 24 hrs prior to clinic visit and/or day of clinic visit
-
At least 3 URI symptoms
Exclusion Criteria:
-
Prior participation in MKC-TI-112
-
MedHist, PE or lab findings of acute bacterial infection including but not limited to sputum prod., nasal/eye discharge, chest exam abnormalities, CXR findings of pneumonia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Research Associates | Tuscon | Arizona | United States | 85712 |
| 2 | Valley Research (Norwood) | Fresno | California | United States | |
| 3 | Diabetes/Lipid Management and Research Center | Huntington Beach | California | United States | 92648 |
| 4 | Private Practice | Decatur | Georgia | United States | 30035 |
| 5 | Endocrine Research Solutions, Inc. | Roswell | Georgia | United States | 30076 |
| 6 | Cedar-Crosse Research Center | Chicago | Illinois | United States | 60607 |
| 7 | MODEL Clinical Research | Baltimore | Maryland | United States | 21204 |
| 8 | Healthcare Research | Florissant | Missouri | United States | 63031 |
| 9 | Billings Clinic Research Division | Billings | Montana | United States | 59101 |
| 10 | New Mexico Clinical Research & Osteoporosis Center | Albuquerque | New Mexico | United States | 87106 |
| 11 | M.E.R.I. | New York | New York | United States | 10023 |
| 12 | Rapid Medical Research Inc | Cleveland | Ohio | United States | 44122 |
| 13 | Your Diabetes Endocrine Nutrition Group | Mentor | Ohio | United States | 44060 |
| 14 | Diabetes & Glandular Disease Research Assoc PA | San Antonio | Texas | United States | 78229 |
| 15 | Magna Center for Family Medicine | Magna | Utah | United States | 84044 |
| 16 | Parkwood Hospital | London | Ontario | Canada | N6C 5J1 |
| 17 | Kemerovo State Medical Academy of Ministry of Health | Kemerovo | RUS | Russian Federation | 650061 |
| 18 | NHI Kemerovo Regional Clinical Hospital | Kemerovo | RUS | Russian Federation | 650061 |
| 19 | Russian State Medical University City Hospital # 4 | Moscow | RUS | Russian Federation | 113093 |
| 20 | RAAMS Endocrinology and Diabetology Department | Moscow | RUS | Russian Federation | 125315 |
| 21 | Clinical Pharm Dept of Yaroslavl Clin Hospital | Yaroslavl | RUS | Russian Federation | 150003 |
| 22 | NHI Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS | Russian Federation | 150062 |
| 23 | Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS | Russian Federation | 150062 |
| 24 | FSI Principal Military Clinical Hospital n.a. academician N.N. Burdenko of the Ministry of Defense | Moscow | Russian Federation | 105229 |
Sponsors and Collaborators
- Mannkind Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00642681
Other Study ID Numbers:
- MKC-TI-112
First Posted:
Mar 25, 2008
Last Update Posted:
Dec 3, 2014
Last Verified:
Dec 1, 2014