NCT00741429

A 2-Month Safety Follow-Up Trial

A 2-Month Safety Follow-up Trial of Subjects From MannKind Protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 649 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up.

Detailed description

This was a 2-month safety follow-up study of subjects from MannKind protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030. No study medications were administered during this trial. The adverse event data included are for the combined Safety population irrespective of previous treatments in the parent trials.

Conditions

• Type 1 Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Technosphere Insulin Inhalation Powder	Subjects previously treated with Technosphere Insulin Inhalation Powder
DRUG	Comparator	Subjects previously treated with other anti-diabetic medications

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-08-26
• Last updated: 2014-12-03

Locations

150 sites across 4 countries: United States, Brazil, Canada, Russia