Clinical trial NCT01201928: Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166
Official title: A Phase 3b, Multicenter, Clinical Trial to Evaluate Pulmonary Function in a Subset of Subjects With Type 1 or Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Interested subjects enrolled in one of three parent trials; MKC-TI-161, MKC-TI-162 or MKC-TI-166

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Baseline values are the average of Visit 1 (Week -7) and Visit 4 (Week 0).
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Valley Research
state: California
city: Long Beach
country: United States
facility: Health Care Partners Medical Group
state: California
city: Atlanta
country: United States
facility: Laureate Clinical Research Group
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Dunwoody
country: United States
facility: Alta Pharmaceutical Research Center
state: Georgia
city: Michigan City
country: United States
facility: LaPorte County Institute for Clinical Research Inc.
state: Indiana
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Research Center
state: Montana
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New Hyde Park
country: United States
facility: North Shore Diabetes and Endocrine Associates
state: New York
city: Greenville
country: United States
facility: Endocrine Research Physicians East PA
state: North Carolina
city: Arlington
country: United States
facility: Israel Hartman MD
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes & Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: SAM Clinical Research Center
state: Texas
Study officials:
References: