A 2-Month Safety Follow-Up Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00741429
First received: August 22, 2008
Last updated: December 1, 2014
Last verified: December 2014
  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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 9 to 27 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
  • Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
  • Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00741429     History of Changes
Other Study ID Numbers: MKC-TI-126
Study First Received: August 22, 2008
Last Updated: December 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 05, 2015