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:
Mannkind Corporation
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
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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:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Insulin human
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: 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
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Contacts
| Contact: MannKind Investigational Site | 6617755300 |
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| United States, Arizona | |
| Withdrawn | |
| Phoenix, Arizona, United States, 85029 | |
| United States, California | |
| Withdrawn | |
| Buena Park, California, United States, 90620 | |
| Not yet recruiting | |
| El Cajon, California, United States, 92020 | |
| Contact: MannKind Investigational Site 6617755300 | |
| Withdrawn | |
| Foothill Ranch, California, United States, 92610 | |
| Withdrawn | |
| Fresno, California, United States, 93726 | |
| Active, not recruiting | |
| Fresno, California, United States, 93720 | |
| Withdrawn | |
| La Mesa, California, United States, 91942 | |
| Active, not recruiting | |
| Long Beach, California, United States, 90806 | |
| Withdrawn | |
| Los Alamitos, California, United States, 90720 | |
| Withdrawn | |
| Los Angeles, California, United States, 90033 | |
| Not yet recruiting | |
| San Diego, California, United States, 92117 | |
| Contact: MannKind Investigational Site 6617755300 | |
| Withdrawn | |
| San Diego, California, United States, 92101 | |
| Not yet recruiting | |
| San Diego, California, United States, 92114 | |
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| United States, Florida | |
| Not yet recruiting | |
| Coral Gables, Florida, United States, 33134 | |
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| Not yet recruiting | |
| Ft. Lauderdale, Florida, United States, 33316 | |
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| Not yet recruiting | |
| Gainesville, Florida, United States, 32608 | |
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| Hialeah, Florida, United States, 33012 | |
| Contact: MannKind Investigational Site 6617755300 | |
| Withdrawn | |
| Miami, Florida, United States, 33136 | |
| Recruiting | |
| Miami, Florida, United States, 33173 | |
| Contact: MannKind Investigational Site 6617755300 | |
| Recruiting | |
| Miami, Florida, United States, 33165 | |
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| Miami, Florida, United States, 33144 | |
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| Recruiting | |
| Miami, Florida, United States, 33186 | |
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| Palm Harbor, Florida, United States, 34652 | |
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| Pembroke Pines, Florida, United States, 33028 | |
| Contact: Mannkind Investigational Site 6617755300 | |
| United States, Georgia | |
| Recruiting | |
| Atlanta, Georgia, United States, 30308 | |
| Contact: MannKind Investigational Site 6617755300 | |
| Withdrawn | |
| Atlanta, Georgia, United States, 30329 | |
| Withdrawn | |
| Dunwoody, Georgia, United States, 30338 | |
| Recruiting | |
| Roswell, Georgia, United States, 30076 | |
| Contact: MannKind Investigational Site 6617755300 | |
| United States, Illinois | |
| Recruiting | |
| Chicago, Illinois, United States, 60607 | |
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| Recruiting | |
| Chicago, Illinois, United States, 60616 | |
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| United States, Indiana | |
| Not yet recruiting | |
| Michigan City, Indiana, United States, 46360 | |
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| United States, Louisiana | |
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| Metairie, Louisiana, United States, 70006 | |
| Contact: MannKind Investigational Site 6617755300 | |
| United States, Maryland | |
| Withdrawn | |
| Baltimore, Maryland, United States, 21237 | |
| United States, Massachusetts | |
| Not yet recruiting | |
| Waltham, Massachusetts, United States, 02453 | |
| Contact: MannKind Investigational Site 6617755300 | |
| United States, Michigan | |
| Withdrawn | |
| Flint, Michigan, United States, 48503 | |
| Recruiting | |
| Flint, Michigan, United States, 48504 | |
| Contact: MannKind Investigational Site 6617755300 | |
| United States, Minnesota | |
| Not yet recruiting | |
| Eagan, Minnesota, United States, 55123 | |
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| United States, Missouri | |
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| St Peters, Missouri, United States, 63376 | |
| Contact: MannKind Investigational Site 6617755300 | |
| United States, Montana | |
| Withdrawn | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Not yet recruiting | |
| Omaha, Nebraska, United States, 67131 | |
| Contact: MannKind Investigational Site 6617755300 | |
| United States, New Hampshire | |
| Not yet recruiting | |
| Nashua, New Hampshire, United States, 03063 | |
| Contact: MannKind Investigational Site 6617755300 | |
| United States, New Mexico | |
| Withdrawn | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Recruiting | |
| Bayside, New York, United States, 11361 | |
| Contact: MannKind Investigational Site 6617755300 | |
| Active, not recruiting | |
| New Hyde Park, New York, United States, 11042 | |
| Recruiting | |
| New York, New York, United States, 10016 | |
| Contact: MannKind Investigational Site 6617755300 | |
| Withdrawn | |
| New York, New York, United States, 10022 | |
| Active, not recruiting | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Recruiting | |
| Charlotte, North Carolina, United States, 28207 | |
| Contact: MannKind Investigational Site 6617755300 | |
| Not yet recruiting | |
| Greenville, North Carolina, United States, 27834 | |
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| Recruiting | |
| Morehead City, North Carolina, United States, 28557 | |
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| United States, Oregon | |
| Recruiting | |
| Medford, Oregon, United States, 97504 | |
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| United States, Pennsylvania | |
| Withdrawn | |
| Downingtown, Pennsylvania, United States, 19335 | |
| Active, not recruiting | |
| Morrisville, Pennsylvania, United States, 19067 | |
| Withdrawn | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Recruiting | |
| Greenville, South Carolina, United States, 29615 | |
| Contact: MannKind Investigational Site 6617755300 | |
| Withdrawn | |
| Greer, South Carolina, United States, 29651 | |
| Recruiting | |
| Rock Hill, South Carolina, United States, 29732 | |
| Contact: MannKind Investigational Site 6617755300 | |
| Recruiting | |
| Spartanburg, South Carolina, United States, 29303 | |
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| Recruiting | |
| Spartanburg, South Carolina, United States, 29302 | |
| Contact: MannKind Investigational Site 6617755300 | |
| United States, Texas | |
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| Arlington, Texas, United States, 76012 | |
| Contact: MannKind Investigational Site, 6617755300 | |
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| Austin, Texas, United States, 78731 | |
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| Dallas, Texas, United States, 75235 | |
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| Dallas, Texas, United States, 75231 | |
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| Recruiting | |
| Dallas, Texas, United States, 75225 | |
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| Houston, Texas, United States, 77079 | |
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| Irving, Texas, United States, 75039 | |
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| North Richland Hills, Texas, United States, 76180 | |
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| San Antonio, Texas, United States, 78205 | |
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| Recruiting | |
| San Antonio, Texas, United States, 78229 | |
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| Recruiting | |
| San Antonio, Texas, United States, 78249 | |
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| Withdrawn | |
| Sugar Land, Texas, United States, 77479 | |
| Not yet recruiting | |
| Tomball, Texas, United States, 77375 | |
| Contact: MannKind Investigational Site 6617755300 | |
| United States, Utah | |
| Withdrawn | |
| Magna, Utah, United States, 84044 | |
| United States, Washington | |
| Not yet recruiting | |
| Federal Way, Washington, United States, 98003 | |
| Contact: MannKind Investigational Site 6617755300 | |
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