Clinical trial NCT00642681: Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Upper Respiratory Infection
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who developed symptoms of URI at any point during the MKC-TI-030 trial and were randomized to study treatment of TI

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


Eligibility 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.

Primary outcomes:
measure: To measure Serum FDKP AUC
timeFrame: 4 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: Arizona Research Associates
state: Arizona
city: Fresno
country: United States
facility: Valley Research (Norwood)
state: California
city: Huntington Beach
country: United States
facility: Diabetes/Lipid Management and Research Center
state: California
city: Decatur
country: United States
facility: Private Practice
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Baltimore
country: United States
facility: MODEL Clinical Research
state: Maryland
city: Florissant
country: United States
facility: Healthcare Research
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Research Division
state: Montana
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center
state: New Mexico
city: New York
country: United States
facility: M.E.R.I.
state: New York
city: Cleveland
country: United States
facility: Rapid Medical Research Inc
state: Ohio
city: Mentor
country: United States
facility: Your Diabetes Endocrine Nutrition Group
state: Ohio
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Assoc PA
state: Texas
city: Magna
country: United States
facility: Magna Center for Family Medicine
state: Utah
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
city: Kemerovo
country: Russian Federation
facility: Kemerovo State Medical Academy of Ministry of Health
state: RUS
city: Kemerovo
country: Russian Federation
facility: NHI Kemerovo Regional Clinical Hospital
state: RUS
city: Moscow
country: Russian Federation
facility: Russian State Medical University City Hospital # 4
state: RUS
city: Moscow
country: Russian Federation
facility: RAAMS Endocrinology and Diabetology Department
state: RUS
city: Yaroslavl
country: Russian Federation
facility: Clinical Pharm Dept of Yaroslavl Clin Hospital
state: RUS
city: Yaroslavl
country: Russian Federation
facility: NHI Yaroslavl Regional Clinical Hospital
state: RUS
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Hospital
state: RUS
city: Moscow
country: Russian Federation
facility: FSI Principal Military Clinical Hospital n.a. academician N.N. Burdenko of the Ministry of Defense
Study officials:
References: