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

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.

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