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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Previous completion of PDC-INS-0008 or MKC-TI-005

• Subjects must be able to attend all scheduled visits and, in the opinion of the Investigator, be able to complete this safety trial

• Subjects must be able to understand English or have access to validated primary language trial documents

• Written informed consent

Exclusion Criteria:

• Drug or alcohol dependency

• Smokers (subjects are expected to remain non-smokers throughout their participation in this trial)

• Known hypersensitivity to the trial drug or to drugs of similar chemical structures

• Anemia (hemoglobin level < 11 g/dL for females or < 12 g/dL for males)

• Evidence of moderate or greater ketones in urine

• Women of childbearing potential practicing inadequate birth control. (Adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, Depo-Provera, contraceptive patches or surgical sterilization)

• Women who are pregnant

• Clinically significant adverse events that remain unresolved from the previous trial and/or clinically significant abnormal laboratory values which are determined by the Investigator or the MKC Medical Monitor to be unsafe or confounding to continued participation