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

December 1, 2014 updated by: Mannkind Corporation

Evaluation of the Effect of Symptomatic Upper Respiratory Infections on Pharmacological Characteristics of Technosphere®/Insulin in Subjects With Diabetes Mellitus After a Meal Challenge

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 5J1
        • Parkwood Hospital
  • Russian Federation
      • Moscow, Russian Federation, 105229
        • FSI Principal Military Clinical Hospital n.a. academician N.N. Burdenko of the Ministry of Defense
    • RUS
      • Kemerovo, RUS, Russian Federation, 650061
        • NHI Kemerovo Regional Clinical Hospital
      • Kemerovo, RUS, Russian Federation, 650061
        • Kemerovo State Medical Academy of Ministry of Health
      • Moscow, RUS, Russian Federation, 125315
        • RAAMS Endocrinology and Diabetology Department
      • Moscow, RUS, Russian Federation, 113093
        • Russian State Medical University City Hospital # 4
      • Yaroslavl, RUS, Russian Federation, 150062
        • NHI Yaroslavl Regional Clinical Hospital
      • Yaroslavl, RUS, Russian Federation, 150003
        • Clinical Pharm Dept of Yaroslavl Clin Hospital
      • Yaroslavl, RUS, Russian Federation, 150062
        • Yaroslavl Regional Clinical Hospital
  • United States
    • Arizona
      • Tuscon, Arizona, United States, 85712
        • Arizona Research Associates
    • California
      • Fresno, California, United States
        • Valley Research (Norwood)
      • Huntington Beach, California, United States, 92648
        • Diabetes/Lipid Management and Research Center
    • Georgia
      • Decatur, Georgia, United States, 30035
        • Private practice
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Model Clinical Research
    • Missouri
      • Florissant, Missouri, United States, 63031
        • HealthCare Research
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Research Division
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • New Mexico Clinical Research & Osteoporosis Center
    • New York
      • New York, New York, United States, 10023
        • M.E.R.I.
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research Inc
      • Mentor, Ohio, United States, 44060
        • Your Diabetes Endocrine Nutrition Group
    • Texas
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Research Assoc PA
    • Utah
      • Magna, Utah, United States, 84044
        • Magna Center for Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1: TI Inhalation Powder
Technosphere® Insulin (TI) Inhalation Powder
Drug: Technosphere Insulin
Technosphere® Insulin (TI) Inhalation Powder, prandial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure Serum FDKP AUC
Time Frame: 4 Hours
4 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mannkind Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

March 21, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKC-TI-112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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