Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00308737
First received: March 28, 2006
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

Pulmonary Safety in Diabetics with T/I


Condition Intervention Phase
Diabetes, Type 1
Diabetes, Type 2
Drug: Technosphere® Insulin Inhalation Powder
Drug: Usual Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Change from Baseline to End of Study in FEV1 by MMRM

  • FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
    FEV1 decrease of ≥ 15% from Baseline value at last measurement


Secondary Outcome Measures:
  • Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
    Change from Baseline to last measurement(Month 24) in FEV1

  • Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
    Change from Baseline to Month 24 in FVC by MMRM

  • Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
    Change from baseline to Month 24 in TLC by MMRM

  • Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
    Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM

  • Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
    FVC Decrease of ≥15% from Baseline Value at Last Measurement

  • Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
    TLC Decrease of ≥ 15% from Baseline Value at Last Measurement

  • 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 ] [ Designated as safety issue: Yes ]
    Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement

  • 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 ] [ Designated as safety issue: Yes ]
    Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement

  • Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c at last measurement

  • Change in Weight From Baseline at Month 24 [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Change from baseline in weight at Month 24


Enrollment: 2053
Study Start Date: June 2005
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TI Inhalation Powder
Technosphere® Insulin Inhalation Powder
Drug: Technosphere® Insulin Inhalation Powder
Inhalation, 15U/30U
Usual care
Usual care
Drug: Usual Care
Subjects will receive antidiabetes treatment at the discretion of their physicians
No Intervention: Non-diabetes
Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00308737

  Show 176 Study Locations
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00308737     History of Changes
Other Study ID Numbers: MKC-TI-030
Study First Received: March 28, 2006
Results First Received: July 22, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014