Evaluate Safety of T/I on Diabetic Subjects With Mild Obstructive Pulmonary Disease

This study is currently recruiting participants.
Verified May 2013 by Mannkind Corporation
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00642616
First received: March 21, 2008
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

Examine the effects of T/I 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 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:


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: T/I Inhalation Powder
Technosphere® Insulin Inhalation Powder
Drug: Technosphere Insulin
Active Comparator: UC
Usual anti diabetic care
Drug: Usual Care

  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 Type1or2 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 cotinin level <100ng/dL
  • Clinical diagnosis of obstructive lung disease

Exclusion Criteria:

  • History of pulmonary exacerbation with 8 wks of screening/V1
  • Post-brochhodilator FEV1 <50%, FVC <70% NHANES III predicted, peformed at the clinical site using office spirometry
  • History of systemic corticosteriod 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 shorty-acting anti-cholingeric 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 steriod in the past 12 mos. for respiratory illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642616

Contacts
Contact: MannKind Investigational Site 6617755300

  Hide Study Locations
Locations
United States, Arizona
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Phoenix, Arizona, United States, 85029
United States, California
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Buena Park, California, United States, 90620
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El Cajon, California, United States, 92020
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Foothill Ranch, California, United States, 92610
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Fresno, California, United States, 93726
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Fresno, California, United States, 93720
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La Mesa, California, United States, 91942
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Long Beach, California, United States, 90806
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Los Alamitos, California, United States, 90720
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Los Angeles, California, United States, 90033
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San Diego, California, United States, 92117
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San Diego, California, United States, 92101
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San Diego, California, United States, 92114
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Coral Gables, Florida, United States, 33134
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Ft. Lauderdale, Florida, United States, 33316
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Hialeah, Florida, United States, 33012
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Miami, Florida, United States, 33136
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Miami, Florida, United States, 33173
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Miami, Florida, United States, 33165
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Miami, Florida, United States, 33144
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Miami, Florida, United States, 33186
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Atlanta, Georgia, United States, 30329
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Dunwoody, Georgia, United States, 30338
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Roswell, Georgia, United States, 30076
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United States, Illinois
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Chicago, Illinois, United States, 60607
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Chicago, Illinois, United States, 60616
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Michigan City, Indiana, United States, 46360
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Metairie, Louisiana, United States, 70006
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United States, Maryland
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Baltimore, Maryland, United States, 21237
United States, Massachusetts
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Waltham, Massachusetts, United States, 02453
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United States, Michigan
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Flint, Michigan, United States, 48503
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Flint, Michigan, United States, 48504
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New York, New York, United States, 10032
United States, North Carolina
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Charlotte, North Carolina, United States, 28207
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Greenville, North Carolina, United States, 27834
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Morehead City, North Carolina, United States, 28557
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United States, Oregon
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Medford, Oregon, United States, 97504
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Morrisville, Pennsylvania, United States, 19067
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Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
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Greenville, South Carolina, United States, 29615
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Greer, South Carolina, United States, 29651
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Rock Hill, South Carolina, United States, 29732
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Spartanburg, South Carolina, United States, 29303
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Spartanburg, South Carolina, United States, 29302
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Houston, Texas, United States, 77079
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Irving, Texas, United States, 75039
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San Antonio, Texas, United States, 78205
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Federal Way, Washington, United States, 98003
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Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Chair: Chief Medical Officer 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: May 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract 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 June 17, 2013