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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
  Purpose

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


Condition Intervention Phase
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
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: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 510
Study Start Date: June 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TI Inhalation Powder
Technosphere® Insulin Inhalation Powder
 Drug: Technosphere Insulin
Inhalation Powder, 15U or 30U, prandial
Active Comparator: UC
Usual anti diabetic care
 Drug: Usual Care
Subject will receive anti-diabetic care at the discretion of their physician

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642616

Contacts
Contact: Chief Scientific Officer 201-983-5000

  Show 29 Study Locations
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00642616     History of Changes
Other Study ID Numbers: MKC-TI-134
Study First Received: March 21, 2008
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Aspiration
Asthma
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013