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Evaluate Safety of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) on Diabetic Subjects With Mild Obstructive Pulmonary Disease

This study is currently recruiting participants.
Verified February 2013 by Mannkind Corporation
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00642616
First received: March 21, 2008
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

March 21, 2008
February 5, 2013
June 2008
August 2015   (final data collection date for primary outcome measure)
Effects of prandially inhaled TI Inhalation Powder in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents versus antidiabetic treatment without TI Inhalation Powder on lung function & pulmonary safety [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
Comparison between the TI and UC Treatment Groups, with respect to change in post-bronchodilator FEV1 from Visit 1 to Final Visit. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00642616 on ClinicalTrials.gov Archive Site
Compare between the treatment groups the effect of treatment on frequency of asthma and COPD exacerbations [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
Additional changes to lung function [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluate Safety of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) on Diabetic Subjects With Mild Obstructive Pulmonary Disease
A Phase 3, Open-label, Randomized Clinical Trial to Evaluate the Safety of Technosphere® Insulin Inhalation Powder(TI Inhalation Powder) in Type 1 or Type 2 Diabetic Subjects With Obstructive Pulmonary Disease (Asthma or Chronic Obstructive Pulmonary Disease [COPD]) Over a 12-Month Treatment Period With a 2-Month Follow-up

Examine the effects of TI Inhalation Powder in combination with an anti-diabetic regimen of insulin vs. anti-diabetic treatment on lung function & pulmonary safety
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetic Type 1 With Obstructive Pulmonary Disease
  • Diabetic Type 2 With Obstructive Pulmonary Disease
  • Asthma
  • COPD
  • Type 1 Diabetes
  • Type 2 Diabetes
  • Indeterminate Obstructive Lung Disease
  • Drug: Technosphere Insulin
    Inhalation Powder, 15U or 30U, prandial
  • Drug: Usual Care
    Subject will receive anti-diabetic care at the discretion of their physician
  • Experimental: TI Inhalation Powder
    Technosphere® Insulin Inhalation Powder
    Intervention: Drug: Technosphere Insulin
  • Active Comparator: UC
    Usual anti diabetic care
    Intervention: Drug: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
510
December 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of Type 1 or 2 diabetes for 12 months and no change in anti-diabetic regiment for at least 90-days prior to screening
  • BMI of 35 kg/m2. A1C 7.0% - 11.0%
  • Non-smoker & urine cotinine level <100ng/dL
  • Clinical diagnosis of obstructive lung disease

Exclusion Criteria:

  • History of pulmonary exacerbation with 8 wks of screening/V1
  • Post-bronchodilator FEV1 <50%, FVC <70% NHANES III predicted, performed at the clinical site using office spirometry
  • History of systemic corticosteroid or antibiotic use of respiratory illness within 8 weeks of V1
  • Treatment with >4 puffs or >2 nebulizer treatments.day of inhaled short-acting beta agonist or short-acting anti-cholinergic agents of a combination of the 2.
  • Treatment with supplemental oxygen therapy, room air oxygen saturation, 94% or history of intubation or ICU admission for respiratory illness in the past 5 yrs.
  • Greater than 2 hospitalizations or ER visits or required >3 courses of systemic steroid in the past 12 mos. for respiratory illness
Both
18 Years to 65 Years
No
Contact: Chief Scientific Officer 201-983-5000
United States
 
NCT00642616
MKC-TI-134
No
Mannkind Corporation
Mannkind Corporation
Not Provided
Not Provided
Mannkind Corporation
February 2013

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