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NCT01201928 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01201928
Other study ID # MKC-TI-164
Secondary ID
Status Terminated
Phase Phase 3
First received August 27, 2010
Last updated December 5, 2012
Start date October 2010
Est. completion date March 2012

Study information
Verified date December 2012
Source Mannkind Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date March 2012
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Israel Hartman MD Arlington Texas
United States Atlanta Diabetes Associates Atlanta Georgia
United States Laureate Clinical Research Group Atlanta Georgia
United States Billings Clinic Research Center Billings Montana
United States Dallas Diabetes & Endocrine Center Dallas Texas
United States Alta Pharmaceutical Research Center Dunwoody Georgia
United States Valley Research Fresno California
United States Endocrine Research Physicians East PA Greenville North Carolina
United States Health Care Partners Medical Group Long Beach California
United States LaPorte County Institute for Clinical Research Inc. Michigan City Indiana
United States Winthrop University Hospital Mineola New York
United States North Shore Diabetes and Endocrine Associates New Hyde Park New York
United States SAM Clinical Research Center San Antonio Texas
United States Washington University School of Medicine St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Mannkind Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). No
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