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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
  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 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mannkind Corporation:

Enrollment: 672
Study Start Date: May 2007
Study Completion Date: September 2008
Primary Completion Date: September 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

  Show 150 Study Locations
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Anders Boss, MD, MFPM, MannKind Corporation
ClinicalTrials.gov Identifier: NCT00741429     History of Changes
Other Study ID Numbers: MKC-TI-126
Study First Received: August 22, 2008
Last Updated: October 1, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013