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A 2-Month Safety Follow-Up Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00741429
First Posted: August 26, 2008
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mannkind Corporation
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes Type 2 Diabetes Drug: Technosphere Insulin Inhalation Powder Drug: Comparator 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:

Primary Outcome Measures:
  • Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 9 to 27 months ]

Secondary Outcome Measures:
  • Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 9 to 27 months ]
  • Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 9 to 27 months ]
  • Change in Hemoglobin Corrected DLco (mL/min/mm Hg) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 9 to 27 months ]
  • Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 3 Months ]
  • Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 3 Months ]
  • Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 3 Months ]
  • Change in Hemoglobin Corrected DLco (mL/min/mmHg) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 3 Months ]

Enrollment: 649
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 Assigned Interventions
Ex-TI
Ex-Technosphere® Insulin Inhalation Powder (subjects previously received TI Inhalation Powder)
Drug: Technosphere Insulin Inhalation Powder
Subjects previously treated with Technosphere Insulin Inhalation Powder
Non Ex-TI
Non Ex-Technosphere® Insulin Inhalation Powder (subjects previously received another anti-diabetic medication)
Drug: Comparator
Subjects previously treated with other anti-diabetic medications

Detailed Description:
This was a 2-month safety follow-up study of subjects from MannKind protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030. No study medications were administered during this trial. The adverse event data included are for the combined Safety population irrespective of previous treatments in the parent trials.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of eligible type 1 and type 2 diabetic subjects who have completed 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741429


  Show 150 Study Locations
Sponsors and Collaborators
Mannkind Corporation
  More Information

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00741429     History of Changes
Other Study ID Numbers: MKC-TI-126
First Submitted: August 22, 2008
First Posted: August 26, 2008
Last Update Posted: December 3, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs