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Completed

NCT Number: NCT00741429

A 2-Month Safety Follow-Up Trial

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technosphere Insulin Inhalation Powder

Drug

Subjects previously treated with Technosphere Insulin Inhalation Powder

Comparator

Drug

Subjects previously treated with other anti-diabetic medications

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mannkind Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 26, 2008
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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