A 2-Month Safety Follow-Up Trial

This study has been completed.

Sponsor:

Information provided by:

Mannkind Corporation

ClinicalTrials.gov Identifier:

NCT00741429

First received: August 22, 2008

Last updated: October 1, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	August 22, 2008
Last Updated Date	October 1, 2009
Start Date ^ICMJE	May 2007
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00741429 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A 2-Month Safety Follow-Up Trial
Official Title ^ICMJE	A 2-Month Safety Follow-up Trial of Subjects From MannKind Protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030
Brief Summary	The purpose of this trial is to compare pulmonary function and pulmonary adverse events in subjects that participated in four previous MKC parent trials.
Detailed Description	A 2-month Safety Follow-Up Trial of Subjects from MannKind Protocols, MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	The study population consists of eligible type 1 and type 2 diabetic subjects participating in any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030).
Condition ^ICMJE	Type 1 Diabetes Type 2 Diabetes
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	1 Previously received TI 2 Previously received another anti-diabetic medication
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	672
Completion Date	September 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Brazil, Canada, Russian Federation

Administrative Information
NCT Number ^ICMJE	NCT00741429
Other Study ID Numbers ^ICMJE	MKC-TI-126
Has Data Monitoring Committee	Not Provided
Responsible Party	Anders Boss, MD, MFPM, MannKind Corporation
Study Sponsor ^ICMJE	Mannkind Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mannkind Corporation
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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