Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge

Completed

• Conditions: Diabetes Mellitus; Upper Respiratory Infection
• Interventions: Drug: Technosphere Insulin

• Registration Number: NCT00642681
• Lead Sponsor: Mannkind Corporation

Brief Summary

Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-25
• Primary Completion: 2008-07
• Study Completion: 2008-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1: TI Inhalation Powder	Technosphere Insulin	Technosphere® Insulin (TI) Inhalation Powder

Primary Outcome Measures

Name	Time	Method
To measure Serum FDKP AUC	4 Hours

Trial Locations

Locations (24)

RAAMS Endocrinology and Diabetology Department; 🇷🇺 Moscow, RUS, Russian Federation

Clinical Pharm Dept of Yaroslavl Clin Hospital; 🇷🇺 Yaroslavl, RUS, Russian Federation

FSI Principal Military Clinical Hospital n.a. academician N.N. Burdenko of the Ministry of Defense; 🇷🇺 Moscow, Russian Federation

Your Diabetes Endocrine Nutrition Group; 🇺🇸 Mentor, Ohio, United States

Magna Center for Family Medicine; 🇺🇸 Magna, Utah, United States

Billings Clinic Research Division; 🇺🇸 Billings, Montana, United States

Yaroslavl Regional Clinical Hospital; 🇷🇺 Yaroslavl, RUS, Russian Federation

Valley Research (Norwood); 🇺🇸 Fresno, California, United States

MODEL Clinical Research; 🇺🇸 Baltimore, Maryland, United States

Diabetes & Glandular Disease Research Assoc PA; 🇺🇸 San Antonio, Texas, United States

Private Practice; 🇺🇸 Decatur, Georgia, United States

Arizona Research Associates; 🇺🇸 Tuscon, Arizona, United States

Diabetes/Lipid Management and Research Center; 🇺🇸 Huntington Beach, California, United States

Cedar-Crosse Research Center; 🇺🇸 Chicago, Illinois, United States

Rapid Medical Research Inc; 🇺🇸 Cleveland, Ohio, United States

Healthcare Research; 🇺🇸 Florissant, Missouri, United States

M.E.R.I.; 🇺🇸 New York, New York, United States

New Mexico Clinical Research & Osteoporosis Center; 🇺🇸 Albuquerque, New Mexico, United States

Parkwood Hospital; 🇨🇦 London, Ontario, Canada

NHI Yaroslavl Regional Clinical Hospital; 🇷🇺 Yaroslavl, RUS, Russian Federation

Kemerovo State Medical Academy of Ministry of Health; 🇷🇺 Kemerovo, RUS, Russian Federation

NHI Kemerovo Regional Clinical Hospital; 🇷🇺 Kemerovo, RUS, Russian Federation

Russian State Medical University City Hospital # 4; 🇷🇺 Moscow, RUS, Russian Federation

Endocrine Research Solutions, Inc.; 🇺🇸 Roswell, Georgia, United States