NCT01201928

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Comparator administered in parent trial	Comparator arm may be different for each parent trial, consisting of some sort of usual care for diabetes
DRUG	Technosphere Insulin Inhalation Powder	Pulmonary delivered inhaled insulin formulation containing human insulin and Technosphere Inhalation Powder (administered in parent trial)

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-03-01
• Completion: 2012-03-01
• First posted: 2010-09-15
• Last updated: 2012-12-06

Locations

14 sites across 1 country: United States