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

N/ATerminatedNCT01201928

Mannkind Corporation3 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Interventions

Comparator administered in parent trialDRUG

Comparator arm may be different for each parent trial, consisting of some sort of usual care for diabetes

Technosphere Insulin Inhalation PowderDRUG

Pulmonary delivered inhaled insulin formulation containing human insulin and Technosphere Inhalation Powder (administered in parent trial)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (14)

Valley Research

Fresno, California, United States

Health Care Partners Medical Group

Long Beach, California, United States

Laureate Clinical Research Group

Outcomes

Primary Outcomes

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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.