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A 2-Month Safety Follow-Up Trial

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ClinicalTrials.gov Identifier: NCT00741429
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Drug: Technosphere Insulin Inhalation Powder Drug: Comparator Phase 3

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.

Study Design

Study Type : Observational
Actual Enrollment : 649 participants
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
Study Start Date : May 2007
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 9 to 27 months ]
  2. Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 9 to 27 months ]
  3. 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 ]
  4. Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 3 Months ]
  5. Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 3 Months ]
  6. Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 3 Months ]
  7. 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 ]

Eligibility Criteria

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


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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 Posted: August 26, 2008    Key Record Dates
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