Status:
COMPLETED
An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
Lead Sponsor:
Mannkind Corporation
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ≥ 4...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT00754624
Start Date
May 1 2004
End Date
October 1 2008
Last Update
October 16 2014
Active Locations (40)
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1
Dorothy L & James E Frank Diabetes Research Institute
San Mateo, California, United States, 94401
2
Sansum Medical Research Institute
Santa Barbara, California, United States, 93105
3
Alliance Medical Group of Greater Waterbury
Middlebury, Connecticut, United States, 06762
4
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050