NCT00754624

An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial

A Four-year, Safety and Tolerability, Open-Label, "Follow on" Trial Evaluating Technosphere® Insulin in Subjects With Type 2 Diabetes Mellitus.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005

Detailed description

This is an uncontrolled study without comparator. Subjects were followed up to 4 years on Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, \& 2 for 48 mo.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler	Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U

Timeline

• Start date: 2004-05-01
• Primary completion: 2008-06-01
• Completion: 2008-10-01
• First posted: 2008-09-18
• Last updated: 2014-10-16
• Results posted: 2014-10-16

Locations

40 sites across 4 countries: United States, Bulgaria, Czechia, Germany