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

NCT ID: NCT01201928

Last Updated: 2012-12-06

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

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Technosphere Insulin Inhalation Powder

Technosphere Insulin Inhalation Powder

Intervention Type DRUG

Pulmonary delivered inhaled insulin formulation containing human insulin and Technosphere Inhalation Powder (administered in parent trial)

Comparator

Based on parent trial

Comparator administered in parent trial

Intervention Type DRUG

Comparator arm may be different for each parent trial, consisting of some sort of usual care for diabetes

Interventions

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Comparator administered in parent trial

Comparator arm may be different for each parent trial, consisting of some sort of usual care for diabetes

Intervention Type DRUG

Technosphere Insulin Inhalation Powder

Pulmonary delivered inhaled insulin formulation containing human insulin and Technosphere Inhalation Powder (administered in parent trial)

Intervention Type DRUG

Eligibility Criteria

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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
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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Valley Research

Fresno, California, United States

Site Status

Health Care Partners Medical Group

Long Beach, California, United States

Site Status

Laureate Clinical Research Group

Atlanta, Georgia, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

Alta Pharmaceutical Research Center

Dunwoody, Georgia, United States

Site Status

LaPorte County Institute for Clinical Research Inc.

Michigan City, Indiana, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Billings Clinic Research Center

Billings, Montana, United States

Site Status

Winthrop University Hospital

Mineola, New York, United States

Site Status

North Shore Diabetes and Endocrine Associates

New Hyde Park, New York, United States

Site Status

Endocrine Research Physicians East PA

Greenville, North Carolina, United States

Site Status

Israel Hartman MD

Arlington, Texas, United States

Site Status

Dallas Diabetes & Endocrine Center

Dallas, Texas, United States

Site Status

SAM Clinical Research Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MKC-TI-164

Identifier Type: -

Identifier Source: org_study_id