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

NCT00754624 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2014-10-16

Study results available
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Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Principal Investigators

  • Anders Boss, MD · Mannkind Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2008-06-30
Completion
2008-10-31

Countries

  • United States
  • Bulgaria
  • Czechia
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00754624 on ClinicalTrials.gov