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
  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:


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 April 15, 2014