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

Completed · Phase 2

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT00754624

Run by

Mannkind Corporation

People needed

229

Starts

2004-05-01

Expected to finish

2008-10-01

Last updated by the study team

2014-10-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Dorothy L & James E Frank Diabetes Research Institute — San Mateo, California, United States
• Sansum Medical Research Institute — Santa Barbara, California, United States
• Alliance Medical Group of Greater Waterbury — Middlebury, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Soundview Research Associates — Norwalk, Connecticut, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Oschner Clinic Foundation — New Orleans, Louisiana, United States
• International Diabetes Center — Minneapolis, Minnesota, United States
• Diabetes Care & Information Center of New York — Flushing, New York, United States
• Diabetes Team Associated — New York, New York, United States
• Endocrine Research - Physician's East PA — Greenville, North Carolina, United States
• Your Diabetes Endocrine Nutrition Group — Mentor, Ohio, United States
• Dallas Diabetes & Endocrine Center — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Texas Diabetes Institute — San Antonio, Texas, United States
• Diabetes & Glandular Disease Research Assoc PA — San Antonio, Texas, United States
• Diabetes Care Center — Seattle, Washington, United States
• MBAL "Pleven" — Pleven, BGR, Bulgaria
• SBALENG-Sofia Institute of Endocrinology — Sofia, BGR, Bulgaria
• MBAL Alexandrovska Hospital — Sofia, BGR, Bulgaria
• Military Medical Academy — Sofia, BGR, Bulgaria
• Central Clinical Base — Sofia, BGR, Bulgaria
• MBAL "Sweta Marina" - Varna — Varna, BGR, Bulgaria
• II-nd MBAL — Sofia, Sofia, Bulgaria
• Military Medical Academy — Sofia, Bulgaria

Full record on ClinicalTrials.gov

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