Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166

December 5, 2012 updated by: Mannkind Corporation

A Phase 3b, Multicenter, Clinical Trial to Evaluate Pulmonary Function in a Subset of Subjects With Type 1 or Type 2 Diabetes

The purpose of this study is to evaluate pulmonary function test (PFT) sub-study in interested subjects from studies MKC-TI-161, MKC-TI-162 and MKC-TI-166. 100 Type I and 100 Type II diabetics will be enrolled. Each subject will undergo 6 PFT assessments over the course of the parent study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study is designed to evaluate and compare changes in pulmonary function (FEV1(forced expiratory volume in 1 second) FVC(forced vital capacity), TLC (total lung capacity) and DLco) in subjects enrolled in 1 of 3 parent trials (MKC-TI-161, MKC-TI-162 or MKC-TI-166). Up to 100 subjects with Type I and Type II diabetes in the TI Inhalation Powder arm, and 100 subjects with Type I and Type II diabetes in the comparator arm will be enrolled. Each subject will undergo 6 PFT assessments over the course of the parent trial.

Study Type

Observational

Enrollment (Actual)

3

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

  • United States
    • California
      • Fresno, California, United States, 93720
        • Valley Research
      • Long Beach, California, United States, 90806
        • Health Care Partners Medical Group
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Laureate Clinical Research Group
      • Atlanta, Georgia, United States, 30309
        • Atlanta Diabetes Associates
      • Dunwoody, Georgia, United States, 30338
        • Alta Pharmaceutical Research Center
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • LaPorte County Institute for Clinical Research Inc.
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Research Center
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 11042
        • North Shore Diabetes and Endocrine Associates
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Endocrine Research Physicians East PA
    • Texas
      • Arlington, Texas, United States, 76014
        • Israel Hartman MD
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes & Endocrine Center
      • San Antonio, Texas, United States, 78229
        • SAM Clinical Research Center

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

Interested subjects enrolled in one of three parent trials; MKC-TI-161, MKC-TI-162 or MKC-TI-166

Description

Inclusion Criteria:

  • Enrollment in one of three parent trials (MKC-TI-161, MKC-TI-162 or MKC-TI-166)

Exclusion Criteria:

  • Subjects who are unable to perform PFTs that meet American Thoracic Society/European Respiratory Society (ATS/ERS) quality recommendations for acceptability and repeatability will be excluded from this study

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
Technosphere Insulin Inhalation Powder
Drug: Technosphere Insulin Inhalation Powder
Pulmonary delivered inhaled insulin formulation containing human insulin and Technosphere Inhalation Powder (administered in parent trial)
Comparator
Based on parent trial
Drug: Comparator administered in parent trial
Comparator arm may be different for each parent trial, consisting of some sort of usual care for diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of change from baseline to final treatment visit in pulmonary function (FEV1 FVC, TLC and DLco) between treatment Groups (TI vs comparator arms) using ANCOVA models.
Time Frame: Baseline values are the average of Visit 1 (Week -7) and Visit 4 (Week 0).
Baseline values are the average of Visit 1 (Week -7) and Visit 4 (Week 0).

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

October 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (ESTIMATE)

September 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKC-TI-164

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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