Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge
This study has been completed.
Sponsor:
Mannkind Corporation
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00642681
First received: March 21, 2008
Last updated: October 1, 2009
Last verified: October 2009
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
Effect of URI on Diabetic Subjects with a meal challenge
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Upper Respiratory Infection |
Drug: Technosphere Insulin Drug: Usual Care |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of the Effect of Symptomatic Upper Respiratory Infections on Pharmacological Characteristics of TechnosphereÒ/Insulin in Subjects With Diabetes Mellitus After a Meal Challenge |
Resource links provided by NLM:
Further study details as provided by Mannkind Corporation:
Primary Outcome Measures:
- To measure Serum FDKP AUC [ Time Frame: 4 Hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Technosphere Insulin
|
Drug: Technosphere Insulin
Inhalation Powder, prandial
|
|
Active Comparator: 2
Usual Care
|
Drug: Usual Care
Subjects will receive anti-diabetes treatment at the discretion of their physician
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642681
Hide Study Locations
Hide Study LocationsLocations
| United States, Arizona | |
| Arizona Research Associates | |
| Tuscon, Arizona, United States, 85712 | |
| United States, California | |
| Valley Research (Norwood) | |
| Fresno, California, United States | |
| Diabetes/Lipid Management and Research Center | |
| Huntington Beach, California, United States, 92648 | |
| United States, Georgia | |
| Private Practice | |
| Decatur, Georgia, United States, 30035 | |
| Endocrine Research Solutions, Inc. | |
| Roswell, Georgia, United States, 30076 | |
| United States, Illinois | |
| Cedar-Crosse Research Center | |
| Chicago, Illinois, United States, 60607 | |
| United States, Maryland | |
| MODEL Clinical Research | |
| Baltimore, Maryland, United States, 21204 | |
| United States, Missouri | |
| Healthcare Research | |
| Florissant, Missouri, United States, 63031 | |
| United States, Montana | |
| Billings Clinic Research Division | |
| Billings, Montana, United States, 59101 | |
| United States, New Mexico | |
| New Mexico Clinical Research & Osteoporosis Center | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| M.E.R.I. | |
| New York, New York, United States, 10023 | |
| United States, Ohio | |
| Rapid Medical Research Inc | |
| Cleveland, Ohio, United States, 44122 | |
| Your Diabetes Endocrine Nutrition Group | |
| Mentor, Ohio, United States, 44060 | |
| United States, Texas | |
| Diabetes & Glandular Disease Research Assoc PA | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Magna Center for Family Medicine | |
| Magna, Utah, United States, 84044 | |
| Canada, Ontario | |
| Parkwood Hospital | |
| London, Ontario, Canada, N6C 5J1 | |
| Russian Federation | |
| Kemerovo State Medical Academy of Ministry of Health | |
| Kemerovo, RUS, Russian Federation, 650061 | |
| NHI Kemerovo Regional Clinical Hospital | |
| Kemerovo, RUS, Russian Federation, 650061 | |
| Russian State Medical University City Hospital # 4 | |
| Moscow, RUS, Russian Federation, 113093 | |
| RAAMS Endocrinology and Diabetology Department | |
| Moscow, RUS, Russian Federation, 125315 | |
| NHI Yaroslavl Regional Clinical Hospital | |
| Yaroslavl, RUS, Russian Federation, 150062 | |
| Yaroslavl Regional Clinical Hospital | |
| Yaroslavl, RUS, Russian Federation, 150062 | |
| Clinical Pharm Dept of Yaroslavl Clin Hospital | |
| Yaroslavl, RUS, Russian Federation, 150003 | |
| 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
More Information
No publications provided
| Responsible Party: | Anders Hasager Boss, MD, MFPM, MannKind Corporation |
| ClinicalTrials.gov Identifier: | NCT00642681 History of Changes |
| Other Study ID Numbers: | MKC-TI-112 |
| Study First Received: | March 21, 2008 |
| Last Updated: | October 1, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Respiratory Tract Infections Common Cold Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Infection Respiratory Tract Diseases |
Picornaviridae Infections RNA Virus Infections Virus Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013