Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mannkind Corporation
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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
