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

Terminated

• Conditions: Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus
• Interventions: Drug: Comparator administered in parent trial; Drug: Technosphere Insulin Inhalation Powder

• Registration Number: NCT01201928
• Lead Sponsor: Mannkind Corporation

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-08-27
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-15
• Study Start: 2010-10
• Primary Completion: 2011-03
• Study Completion: 2012-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Comparator	Comparator administered in parent trial	Based on parent trial
Technosphere Insulin Inhalation Powder	Technosphere Insulin Inhalation Powder	-

Primary Outcome Measures

Name	Time	Method
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.	Baseline values are the average of Visit 1 (Week -7) and Visit 4 (Week 0).

Trial Locations

Locations (14)

Billings Clinic Research Center; 🇺🇸 Billings, Montana, United States

SAM Clinical Research Center; 🇺🇸 San Antonio, Texas, United States

Valley Research; 🇺🇸 Fresno, California, United States

Laureate Clinical Research Group; 🇺🇸 Atlanta, Georgia, United States

Health Care Partners Medical Group; 🇺🇸 Long Beach, California, United States

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States

North Shore Diabetes and Endocrine Associates; 🇺🇸 New Hyde Park, New York, United States

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States

Alta Pharmaceutical Research Center; 🇺🇸 Dunwoody, Georgia, United States

LaPorte County Institute for Clinical Research Inc.; 🇺🇸 Michigan City, Indiana, United States

Endocrine Research Physicians East PA; 🇺🇸 Greenville, North Carolina, United States

Israel Hartman MD; 🇺🇸 Arlington, Texas, United States

Dallas Diabetes & Endocrine Center; 🇺🇸 Dallas, Texas, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States