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

March 28, 2006
October 9, 2014
June 2005
September 2008   (final data collection date for primary outcome measure)
  • 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
  • Compare the incidence of a decrease in FEV1 of 15% or more
  • Evaluate and compare changes in pulmonary function as measured by forced
  • expiratory volume in 1 second (FEV1)
Complete list of historical versions of study NCT00308737 on ClinicalTrials.gov Archive Site
  • 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
  • Evaluate and compare the change in forced vital capacity (FVC), total lung
  • capacity (TLC) and single–breath carbon monoxide diffusing capacity of the lung
  • (DLco)
  • Evaluate the incidence of a decrease in FVC or TLC of 15% or more, or a
  • decrease in DLco of more than 3 mLCO/min/mmHg
  • Evaluate and compare HbA1c between the 2 diabetes treatment groups and to evaluate and compare the incidence and frequency of defined
  • hypoglycemia between the 2 diabetes treatment groups
  • Evaluate and compare changes in lung function between subjects with diabetes and subjects without abnormalities in glucose metabolism
  • Compare changes in diabetes treatment groups as a function of baseline glycemic control.
Not Provided
Not Provided
 
Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
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.

Pulmonary Safety in Diabetics with T/I

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes, Type 1
  • Diabetes, Type 2
  • Drug: Technosphere® Insulin Inhalation Powder
    Inhalation, 15U/30U
  • Drug: Usual Care
    Subjects will receive antidiabetes treatment at the discretion of their physicians
  • Experimental: TI Inhalation Powder
    Technosphere® Insulin Inhalation Powder
    Intervention: Drug: Technosphere® Insulin Inhalation Powder
  • Usual care
    Usual care
    Intervention: Drug: Usual Care
  • No Intervention: Non-diabetes
    Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2053
October 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain,   United States,   Canada,   United Kingdom,   Ukraine,   Russian Federation,   Czech Republic,   Poland
 
NCT00308737
MKC-TI-030
Not Provided
Mannkind Corporation
Mannkind Corporation
Not Provided
Not Provided
Mannkind Corporation
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP