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
• 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

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

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