A 2-Month Safety Follow-Up Trial

This study is currently recruiting participants.

Verified by Mannkind Corporation, August 2008

Sponsored by:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00741429

Purpose

The purpose of this trial is to compare pulmonary function and pulmonary adverse events in subjects that participated in four previous MKC parent trials.

Condition	Phase
Type 1 Diabetes Type 2 Diabetes	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	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

Further study details as provided by Mannkind Corporation:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	666
Study Start Date:	May 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Previously received TI
2 Previously received another anti-diabetic medication

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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).

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741429

Contacts

Contact: Anders Boss, MD, MFPM

201-983-5011

aboss@mannkindcorp.com

Show 150 Study Locations

Sponsors and Collaborators

Mannkind Corporation

More Information

Responsible Party:	MannKind Corporation ( Anders Boss, MD, MFPM )
Study ID Numbers:	MKC-TI-126
Study First Received:	August 22, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00741429
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009