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

MannKind

Status: Terminated

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Treatments: Drug: Technosphere Insulin Inhalation Powder; Drug: Comparator administered in parent trial

Study type: Observational

Funder types: Industry

Identifiers

NCT01201928

MKC-TI-164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

3 participants in 2 patient groups

Technosphere Insulin Inhalation Powder

Treatment:

Drug: Technosphere Insulin Inhalation Powder

Comparator

Description:

Based on parent trial

Treatment:

Drug: Comparator administered in parent trial