A 2-Month Safety Follow-Up Trial

Completed

Conditions studied: Type 1 Diabetes, Type 2 Diabetes

In brief

The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up.

Key facts

Study ID

NCT00741429

Run by

Mannkind Corporation

People needed

649

Starts

2007-05-01

Expected to finish

2008-09-01

Last updated by the study team

2014-12-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030)
• Urine cotinine test of less than or equal to 100 ng/mL
• Written informed consent

You may not qualify if…

• Subjects who started smoking during the 4 week follow-up phase of the parent trial
• Subjects who began a new inhaled insulin regimen with an investigational drug during the 4 week follow-up phase of the parent trial and/or are participation in another clinical trial
• Female subjects who are pregnant, lactating or planning on becoming pregnant
• Subjects with a positive urine drug screening at Visit 1
• Female subjects of child-bearing potential not practicing adequate birth control

Where it is running

• Coastal Clinical Research Inc — Mobile, Alabama, United States
• Radiant Research (Phoenix) — Chandler, Arizona, United States
• Southwest Health Ltd Research Division — Phoenix, Arizona, United States
• Northwest Medical Center — Phoenix, Arizona, United States
• Canyon Clinical Research — Tucson, Arizona, United States
• Arizona Research Associates — Tuscon, Arizona, United States
• Private Practice — Burlingame, California, United States
• International Clinical Research Network — Chula Vista, California, United States
• Family Medical Center — Foothill Ranch, California, United States
• Saad Hijazi MD Inc — Fresno, California, United States
• Saint Agnes Medical Center — Fresno, California, United States
• Valley Research — Fresno, California, United States
• Digestive & Liver Disease Specialist A Medical Group Inc — Garden Grove, California, United States
• Diabetes/Lipid Management and Research Center — Huntington Beach, California, United States
• Interlink Research Institute — Los Alamitos, California, United States
• Southern California Endocrine Center — Pasadena, California, United States
• Dorothy L & James E Frank Diabetes Research Institute — San Mateo, California, United States
• Sansum Medical Research Institute — Santa Barbara, California, United States
• Coastal Biomedical Research Inc — Santa Monica, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Diabetes Research Center — Tustin, California, United States
• Creekside Endocrine Associates — Denver, Colorado, United States
• Chase Medical Research LLC — Waterbury, Connecticut, United States
• Center for Diabetes & Endocrine Care — Hollywood, Florida, United States
• Parkway Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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