Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge
Evaluation of the Effect of Symptomatic Upper Respiratory Infections on Pharmacological Characteristics of Technosphere®/Insulin in Subjects With Diabetes Mellitus After a Meal Challenge
1 other identifier
observational
20
3 countries
24
Brief Summary
Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2007
Shorter than P25 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 21, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedDecember 3, 2014
December 1, 2014
7 months
March 21, 2008
December 1, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
To measure Serum FDKP AUC
4 Hours
Study Arms (1)
1: TI Inhalation Powder
Technosphere® Insulin (TI) Inhalation Powder
Interventions
Technosphere® Insulin (TI) Inhalation Powder, prandial
Eligibility Criteria
Subjects who developed symptoms of URI at any point during the MKC-TI-030 trial and were randomized to study treatment of TI
You may qualify if:
- Clinical diagnosis of URI with in 24 hrs prior to clinic visit and/or day of clinic visit
- At least 3 URI symptoms
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Arizona Research Associates
Tuscon, Arizona, 85712, United States
Valley Research (Norwood)
Fresno, California, United States
Diabetes/Lipid Management and Research Center
Huntington Beach, California, 92648, United States
Private Practice
Decatur, Georgia, 30035, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
MODEL Clinical Research
Baltimore, Maryland, 21204, United States
Healthcare Research
Florissant, Missouri, 63031, United States
Billings Clinic Research Division
Billings, Montana, 59101, United States
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, 87106, United States
M.E.R.I.
New York, New York, 10023, United States
Rapid Medical Research Inc
Cleveland, Ohio, 44122, United States
Your Diabetes Endocrine Nutrition Group
Mentor, Ohio, 44060, United States
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, 78229, United States
Magna Center for Family Medicine
Magna, Utah, 84044, United States
Parkwood Hospital
London, Ontario, N6C 5J1, Canada
Kemerovo State Medical Academy of Ministry of Health
Kemerovo, RUS, 650061, Russia
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, 650061, Russia
Russian State Medical University City Hospital # 4
Moscow, RUS, 113093, Russia
RAAMS Endocrinology and Diabetology Department
Moscow, RUS, 125315, Russia
Clinical Pharm Dept of Yaroslavl Clin Hospital
Yaroslavl, RUS, 150003, Russia
NHI Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, 150062, Russia
Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, 150062, Russia
FSI Principal Military Clinical Hospital n.a. academician N.N. Burdenko of the Ministry of Defense
Moscow, 105229, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2008
First Posted
March 25, 2008
Study Start
December 1, 2007
Primary Completion
July 1, 2008
Study Completion
August 1, 2008
Last Updated
December 3, 2014
Record last verified: 2014-12