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

NCT ID: NCT00642681

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-08-31

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus Upper Respiratory Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1: TI Inhalation Powder

Technosphere® Insulin (TI) Inhalation Powder

Technosphere Insulin

Intervention Type DRUG

Technosphere® Insulin (TI) Inhalation Powder, prandial

Interventions

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Technosphere Insulin

Technosphere® Insulin (TI) Inhalation Powder, prandial

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mannkind Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Research Associates

Tuscon, Arizona, United States

Site Status

Valley Research (Norwood)

Fresno, California, United States

Site Status

Diabetes/Lipid Management and Research Center

Huntington Beach, California, United States

Site Status

Private Practice

Decatur, Georgia, United States

Site Status

Endocrine Research Solutions, Inc.

Roswell, Georgia, United States

Site Status

Cedar-Crosse Research Center

Chicago, Illinois, United States

Site Status

MODEL Clinical Research

Baltimore, Maryland, United States

Site Status

Healthcare Research

Florissant, Missouri, United States

Site Status

Billings Clinic Research Division

Billings, Montana, United States

Site Status

New Mexico Clinical Research & Osteoporosis Center

Albuquerque, New Mexico, United States

Site Status

M.E.R.I.

New York, New York, United States

Site Status

Rapid Medical Research Inc

Cleveland, Ohio, United States

Site Status

Your Diabetes Endocrine Nutrition Group

Mentor, Ohio, United States

Site Status

Diabetes & Glandular Disease Research Assoc PA

San Antonio, Texas, United States

Site Status

Magna Center for Family Medicine

Magna, Utah, United States

Site Status

Parkwood Hospital

London, Ontario, Canada

Site Status

Kemerovo State Medical Academy of Ministry of Health

Kemerovo, RUS, Russia

Site Status

NHI Kemerovo Regional Clinical Hospital

Kemerovo, RUS, Russia

Site Status

Russian State Medical University City Hospital # 4

Moscow, RUS, Russia

Site Status

RAAMS Endocrinology and Diabetology Department

Moscow, RUS, Russia

Site Status

Clinical Pharm Dept of Yaroslavl Clin Hospital

Yaroslavl, RUS, Russia

Site Status

NHI Yaroslavl Regional Clinical Hospital

Yaroslavl, RUS, Russia

Site Status

Yaroslavl Regional Clinical Hospital

Yaroslavl, RUS, Russia

Site Status

FSI Principal Military Clinical Hospital n.a. academician N.N. Burdenko of the Ministry of Defense

Moscow, , Russia

Site Status

Countries

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United States Canada Russia

Other Identifiers

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MKC-TI-112

Identifier Type: -

Identifier Source: org_study_id