Study Stopped
Parent trials were either not initiated or terminated
Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166
A Phase 3b, Multicenter, Clinical Trial to Evaluate Pulmonary Function in a Subset of Subjects With Type 1 or Type 2 Diabetes
1 other identifier
observational
3
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2010
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2010
CompletedFirst Posted
Study publicly available on registry
September 15, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedDecember 6, 2012
December 1, 2012
5 months
August 27, 2010
December 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Study Arms (2)
Technosphere Insulin Inhalation Powder
Comparator
Based on parent trial
Interventions
Comparator arm may be different for each parent trial, consisting of some sort of usual care for diabetes
Pulmonary delivered inhaled insulin formulation containing human insulin and Technosphere Inhalation Powder (administered in parent trial)
Eligibility Criteria
Interested subjects enrolled in one of three parent trials; MKC-TI-161, MKC-TI-162 or MKC-TI-166
You may qualify if:
- Enrollment in one of three parent trials (MKC-TI-161, MKC-TI-162 or MKC-TI-166)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Valley Research
Fresno, California, 93720, United States
Health Care Partners Medical Group
Long Beach, California, 90806, United States
Laureate Clinical Research Group
Atlanta, Georgia, 30308, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30309, United States
Alta Pharmaceutical Research Center
Dunwoody, Georgia, 30338, United States
LaPorte County Institute for Clinical Research Inc.
Michigan City, Indiana, 46360, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Billings Clinic Research Center
Billings, Montana, 59101, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, 11042, United States
Endocrine Research Physicians East PA
Greenville, North Carolina, 27834, United States
Israel Hartman MD
Arlington, Texas, 76014, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230, United States
SAM Clinical Research Center
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2010
First Posted
September 15, 2010
Study Start
October 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2012
Last Updated
December 6, 2012
Record last verified: 2012-12