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OpenTrials
Completed

NCT Number: NCT00308737

Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

Pulmonary Safety in Diabetics with T/I

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Finchlea Medical Group, Brampton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • For All Subjects:
  • Nonsmoking
  • Body mass index <42 kg/m2
  • FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening,
  • No abnormalities in screening pulmonary radiology
  • For Subjects with diabetes mellitus:
  • Type 1 or type 2 diabetes for at least 2 years
  • HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 %
  • For Subjects without abnormalities in glucose control:
  • No history of diabetes
  • Normal results from a formal glucose tolerance test

Exclusion criteria

  • History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease
  • Significant renal, hepatic, or cardiac disease
  • Women who are pregnant, lactating, or planning on becoming pregnant
  • Subjects who have participated in studies of other investigational drugs within the previous 3 months
  • Evidence of severe complications of diabetes

Treatment and study plan

Technosphere® Insulin Inhalation Powder

Drug

Inhalation, 15U/30U

Usual Care

Drug

Subjects will receive antidiabetes treatment at the discretion of their physicians

Primary outcomes

  1. Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care

    Time frame: Baseline to Month 24

    Change from Baseline to End of Study in FEV1 by MMRM

  2. FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care

    Time frame: Baseline to Month 24

    FEV1 decrease of ≥ 15% from Baseline value at last measurement

Secondary outcomes

  1. Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care

    Time frame: Baseline to Month 24

    Change from Baseline to last measurement(Month 24) in FEV1

  2. Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM

    Time frame: Baseline to Month 24

    Change from Baseline to Month 24 in FVC by MMRM

  3. Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM

    Time frame: Baseline to Month 24

    Change from baseline to Month 24 in TLC by MMRM

  4. Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM

    Time frame: Baseline to Month 24

    Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM

  5. Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement

    Time frame: Baseline to Month 24

    FVC Decrease of ≥15% from Baseline Value at Last Measurement

  6. Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement

    Time frame: Baseline to Month 24

    TLC Decrease of ≥ 15% from Baseline Value at Last Measurement

  7. Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement

    Time frame: Baseline to Month 24

    Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement

  8. Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement

    Time frame: Baseline to Month 24

    Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement

  9. Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care

    Time frame: Baseline to Month 24

    Change from baseline in HbA1c at last measurement

  10. Change in Weight From Baseline at Month 24

    Time frame: Baseline to Month 24

    Change from baseline in weight at Month 24

Sponsors and collaborators

Lead sponsor

Mannkind Corporation

Industry

Registry information

Official study title

Pulmonary Outcomes Within a 2-Year Period in Subjects With Diabetes Mellitus Treated With Technosphere /Insulin or Usual Antidiabetic Treatment and in Subjects Without Abnormalities in Glucose Control.

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 30, 2006
Registry last updated
Oct 16, 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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