Diabetes Mellitus Clinical Trial
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
| Verified date | December 2014 |
| Source | Mannkind Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Observational |
Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | August 2008 |
| Est. primary completion date | July 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | Parkwood Hospital | London | Ontario |
| Russian Federation | Kemerovo State Medical Academy of Ministry of Health | Kemerovo | RUS |
| Russian Federation | NHI Kemerovo Regional Clinical Hospital | Kemerovo | RUS |
| Russian Federation | FSI Principal Military Clinical Hospital n.a. academician N.N. Burdenko of the Ministry of Defense | Moscow | |
| Russian Federation | RAAMS Endocrinology and Diabetology Department | Moscow | RUS |
| Russian Federation | Russian State Medical University City Hospital # 4 | Moscow | RUS |
| Russian Federation | Clinical Pharm Dept of Yaroslavl Clin Hospital | Yaroslavl | RUS |
| Russian Federation | NHI Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS |
| Russian Federation | Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS |
| United States | New Mexico Clinical Research & Osteoporosis Center | Albuquerque | New Mexico |
| United States | MODEL Clinical Research | Baltimore | Maryland |
| United States | Billings Clinic Research Division | Billings | Montana |
| United States | Cedar-Crosse Research Center | Chicago | Illinois |
| United States | Rapid Medical Research Inc | Cleveland | Ohio |
| United States | Private Practice | Decatur | Georgia |
| United States | Healthcare Research | Florissant | Missouri |
| United States | Valley Research (Norwood) | Fresno | California |
| United States | Diabetes/Lipid Management and Research Center | Huntington Beach | California |
| United States | Magna Center for Family Medicine | Magna | Utah |
| United States | Your Diabetes Endocrine Nutrition Group | Mentor | Ohio |
| United States | M.E.R.I. | New York | New York |
| United States | Endocrine Research Solutions, Inc. | Roswell | Georgia |
| United States | Diabetes & Glandular Disease Research Assoc PA | San Antonio | Texas |
| United States | Arizona Research Associates | Tuscon | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Mannkind Corporation |
United States, Canada, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To measure Serum FDKP AUC | 4 Hours | No |
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