Evaluate Safety of TI in Diabetic Subjects With Moderate Obstructive Pulmonary Disease (Asthma and COPD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Mannkind Corporation
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00642616
First received: March 21, 2008
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

Examine the effects of TI 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 Asthma or COPD
Diabetic Type 2 With Asthma or 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:
  • To compare safety of provided TI in combination with any other diabetic agents versus Anti-diabetic agents without TI (UC Group) in Type 1 or Type 2 diabetic subjects with Asthma or COPD with respect to lung function. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare between the treatment groups the effect treatment: on Glycemic control, Frequency of pulmonary exacerbations, acute changes in lung function from after TI inhalation, Health related quality of life assessment. [ 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
Technosphere® Insulin Inhalation Powder
Drug: Technosphere Insulin
Active Comparator: Usual Care with Anti-diabetic agents
Usual anti diabetic care
Drug: Usual Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Asthma

  • Physician diagnosis of asthma with history of any or all of the following: recurrent wheezing, recurrent chest tightness, recurrent difficulty breathing, or cough, particularly worse at nighttime
  • Never smoked or former smokers (= 6 months since cessation)
  • ≥18 years of age
  • Prebronchodilator FEV1 ≥ 60% Third National Health and Nutrition Examination Survey (NHANES III) predicted, prebronchodilator total lung capacity (TLC) ≥ 80% predicted Intermountain Thoracic Society (ITS), and prebronchodilator single breath carbon monoxide diffusing capacity of the lung (DLco) (unc) ≥70% predicted (Miller)
  • < 30% day-to-day variability in daily morning PEF during the 2-week run-in period
  • Significant improvement in pre- to postbronchodilator spirometry (defined as an increase from baseline of ≥ 12% and ≥ 200 mL in FEV1 or forced vital capacity [FVC]) at Screening/Visit 1 or documented significant improvement in pre- to postbronchodilator spirometry (as defined above) within past 12 months in subject's medical records or a documented positive methacholine challenge test within the past 12 months

COPD

  • Physician diagnosis of COPD (including emphysema and/or chronic bronchitis), history of dyspnea and/or intermittent or daily chronic cough with or without sputum production, not attributable to any other known cause
  • Former smoker (≥ 6 months since cessation) with smoking history of ≥ 10 pack years
  • ≥40 years of age
  • Postbronchodilator FEV1/FVC ratio < 70%
  • Postbronchodilator FEV1 ≥ 50% NHANES III predicted, total lung capacity (TLC) ≥ 80% predicted ITS, and DLco (unc) ≥ 50% predicted (Miller)

Both

  • Clinical diagnosis of Type1 or 2 diabetes mellitus for ≥ 12 months and no change in anti-diabetic regiment for at least 90-days prior to screening
  • BMI of, < 39 kg/m2
  • Urine cotinine level ≤ 100ng/dL
  • Clinical diagnosis of obstructive lung disease
  • HbA1C > 6.5% ≤ 11.5%

Exclusion Criteria:

  • History of pulmonary exacerbation within 8 weeks of screening/V1 or between V1 and V2
  • Use of systemic corticosteroids or antibiotics for respiratory illness within 8 weeks of screening/V1 OR between V1 and V2
  • Increase from baseline in the use of short-acting bronchodilator or short-acting anticholinergic agents, or the combination of the 2, by ≥6 puffs or ≥3 nebulizer treatments per day for ≥ 2 days
  • 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 or urgent care visits or required >3 courses of systemic steroid in the past 12 months for respiratory illness
  • Use of Symlin® (pramlintide acetate) within the preceding 90 days
  • Two or more severe hypoglycemic episodes within 6 months of screening or episode of severe hypoglycemia between Screening and Baseline
  • Previous exposure to any inhaled insulin product
  • Currently using an insulin delivery pump
  • Requires significant change (define as initiation of a new medication or change in the dose or frequency of the controller medications) in the asthma or COPD therapeutic regimen within 8 weeks of Screening/Visit 1 (Week -4) or between Visit 1 and Baseline/Visit 2
  • Severe complications of diabetes mellitus, in the opinion of the PI or sub-investigator, including symptomatic autonomic neuropathy; disabling peripheral neuropathy; active proliferative retinopathy; nephropathy with renal failure, renal transplant and/or dialysis; history of foot ulcers; nontraumatic amputations due to gangrene; and/or vascular claudication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: MannKind Investigational Site 6617755300

  Hide Study Locations
Locations
United States, Arizona
Recruiting
Flagstaff, Arizona, United States, 86001
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Withdrawn
Phoenix, Arizona, United States, 85029
United States, California
Withdrawn
Buena Park, California, United States, 90620
Recruiting
El Cajon, California, United States, 92020
Contact: MannKind Investigational Site    6617755300      
Withdrawn
Foothill Ranch, California, United States, 92610
Completed
Fresno, California, United States, 93726
Active, not recruiting
Fresno, California, United States, 93720
Withdrawn
La Mesa, California, United States, 91942
Completed
Long Beach, California, United States, 90806
Completed
Los Alamitos, California, United States, 90720
Withdrawn
Los Angeles, California, United States, 90033
Recruiting
Mission Hills, California, United States, 91345
Contact: MannKind Investigational Site    6617755300      
Recruiting
San Diego, California, United States, 92117
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Withdrawn
San Diego, California, United States, 92101
Recruiting
San Diego, California, United States, 92114
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Withdrawn
West Hills, California, United States, 91307
United States, Florida
Recruiting
Brandon, Florida, United States, 33511
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Withdrawn
Clearwater, Florida, United States, 33765
Recruiting
Clearwater, Florida, United States, 33756
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Recruiting
Coral Gables, Florida, United States, 33134
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Withdrawn
Ft. Lauderdale, Florida, United States, 33316
Withdrawn
Gainesville, Florida, United States, 32608
Withdrawn
Hialeah, Florida, United States, 33012
Recruiting
Hollywood, Florida, United States, 33024
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Recruiting
Miami, Florida, United States, 33142
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Miami, Florida, United States, 33155
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Miami, Florida, United States, 33165
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Miami, Florida, United States, 33144
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Completed
Miami, Florida, United States, 33136
Recruiting
Miami, Florida, United States, 33186
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Withdrawn
Miami Beach, Florida, United States, 33140
Recruiting
New Port Richey, Florida, United States, 34652
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Recruiting
Orlando, Florida, United States, 32804
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Withdrawn
Palm Harbor, Florida, United States, 34684
Active, not recruiting
Pembroke Pines, Florida, United States, 33028
Recruiting
Pinellas Park, Florida, United States, 33782
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Active, not recruiting
Pinellas Park, Florida, United States, 33782
United States, Georgia
Recruiting
Atlanta, Georgia, United States, 30308
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Completed
Atlanta, Georgia, United States, 30329
Withdrawn
Dunwoody, Georgia, United States, 30338
Withdrawn
Roswell, Georgia, United States, 30076
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60607
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Chicago, Illinois, United States, 60616
United States, Indiana
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Michigan City, Indiana, United States, 46360
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United States, Louisiana
Completed
Metairie, Louisiana, United States, 70002
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Metairie, Louisiana, United States, 70006
United States, Maryland
Recruiting
Annapolis, Maryland, United States, 21401
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Completed
Baltimore, Maryland, United States, 21237
United States, Massachusetts
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Waltham, Massachusetts, United States, 02453
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United States, Michigan
Completed
Flint, Michigan, United States, 48503
Recruiting
Flint, Michigan, United States, 48504
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United States, Minnesota
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Eagan, Minnesota, United States, 55123
United States, Missouri
Withdrawn
St Peters, Missouri, United States, 63376
Recruiting
St. Louis, Missouri, United States, 63141
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United States, Montana
Completed
Billings, Montana, United States, 59101
United States, Nebraska
Recruiting
Omaha, Nebraska, United States, 68131
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United States, New Hampshire
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Nashua, New Hampshire, United States, 03063
United States, New Mexico
Completed
Albuquerque, New Mexico, United States, 87106
United States, New York
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Bayside, New York, United States, 11361
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Completed
New Hyde Park, New York, United States, 11042
Active, not recruiting
New York, New York, United States, 10032
Completed
New York, New York, United States, 10022
Withdrawn
New York, New York, United States, 10016
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States, 28207
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Completed
Greenville, North Carolina, United States, 27834
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
Completed
Downingtown, Pennsylvania, United States, 19335
Withdrawn
Morrisville, Pennsylvania, United States, 19067
Withdrawn
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Recruiting
Greenville, South Carolina, United States, 29615
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Completed
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, 29302
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Spartanburg, South Carolina, United States, 29303
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United States, Texas
Recruiting
Arlington, Texas, United States, 76012
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Completed
Austin, Texas, United States, 78731
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Dallas, Texas, United States, 75231
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Recruiting
Dallas, Texas, United States, 75218
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Recruiting
Dallas, Texas, United States, 75225
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Recruiting
Georgetown, Texas, United States, 78626
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Withdrawn
Houston, Texas, United States, 77079
Withdrawn
Hurst, Texas, United States, 76054
Recruiting
Irving, Texas, United States, 75039
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Not yet recruiting
Irving, Texas, United States, 75039
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Recruiting
North Richland Hills, Texas, United States, 76180
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Completed
San Antonio, Texas, United States, 78229
Withdrawn
San Antonio, Texas, United States, 78205
Completed
San Antonio, Texas, United States, 78249
Withdrawn
Sugar Land, Texas, United States, 77479
Recruiting
Tomball, Texas, United States, 77375
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United States, Utah
Completed
Magna, Utah, United States, 84044
United States, Washington
Completed
Federal Way, Washington, United States, 98003
Recruiting
Tacoma, Washington, United States, 98405
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United States, Wisconsin
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Kenosha, Wisconsin, United States, 53142
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Argentina
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Mar del Plata, Buenos Aires, Argentina, B7602DCK
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Mar del Plata, Buenos Aires, Argentina, 7600
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Buenos Aires, Argentina, 1425
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Buenos Aires, Argentina, C1425DES
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Buenos Aires, Argentina, C1425AGC
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Buenos Aires, Argentina, C1419AHN
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Buenos Aires, Argentina, C1120AAC
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Mendoza, Argentina, 5500
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Brazil
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Fortaleza, Ceara, Brazil, 60115-282
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Fortaleza, Ceará, Brazil, 60430-370
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Belem, Para, Brazil, 66073-000
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Porto Alegre, RS, Brazil, 90035-170
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Campinas, Sao Paulo, Brazil, 13073-350
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Mogi das Cruzes, Sao Paulo, Brazil, 08780-090
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Santo André, Sao Paulo, Brazil, 09060-650
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Sao Jose, Sao Paulo, Brazil, 15090-000
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São Bernardo do Campo, Sao Paulo, Brazil, 09780-000
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Porto Alegre, Brazil, 90035-070
Not yet recruiting
Porto Alegre, Brazil, 91350-250
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Not yet recruiting
Sao Paulo, Brazil, 01244-030
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Not yet recruiting
Sao Paulo, Brazil, 05403-900
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Chile
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Santiago, Chile
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Santiago, Chile, 7850000
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Santiago, Chile, 8330008
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Viña del Mar, Chile, 2520000
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Germany
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Aschaffenburg, Bayern, Germany, 63739
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Berlin, DEU, Germany, D 10115
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Frankfurt, Hessen, Germany, 60596
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Essen, Nordrhein Westfalen, Germany, 45355
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Goch, Nordrhein Westfalen, Germany, 47574
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Hungary
Recruiting
Budapest, Hungary, 1145
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Withdrawn
Budapest, Hungary, 1125
Recruiting
Budapest, Hungary, 1033
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Russian Federation
Recruiting
Moscow, Russia, Russian Federation, 125367
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Recruiting
Moscow, RUS, Russian Federation, 107150
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Recruiting
Yaroslavl, RUS, Russian Federation, 150002
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Recruiting
Kemerovo, RU, Russian Federation, 650066
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Recruiting
Moscow, RU, Russian Federation, 121374
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Recruiting
Moscow, RU, Russian Federation, 117036
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Completed
Moscow, RU, Russian Federation, 129128
Withdrawn
Moscow, RU, Russian Federation, 117593
Recruiting
Moscow, RU, Russian Federation, 105120
Contact: MannKind Investigational Site    6617755300      
Withdrawn
Moscow, RU, Russian Federation, 119435
Withdrawn
Petrozavodsk, RU, Russian Federation, 185019
Recruiting
St Petersburg, RU, Russian Federation, 194291
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Recruiting
St Petersburg, RU, Russian Federation, 198013
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Recruiting
St. Petersburg, RU, Russian Federation, 191186
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Recruiting
St. Petersburg, RU, Russian Federation, 191015
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Recruiting
St. Petersburg, RU, Russian Federation, 194354
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Recruiting
St. Petersburg, RU, Russian Federation, 191119
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Withdrawn
St. Petersburg, RU, Russian Federation, 196601
Recruiting
Yaroslavl, RU, Russian Federation, 150003
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Slovakia
Withdrawn
Bratislava, Slovakia, 82106
Withdrawn
Bratislava, Slovakia, 82606
Recruiting
Liptovsky Hradok, Slovakia, 03301
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Recruiting
Martin, Slovakia, 03659
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Withdrawn
Nitra, Slovakia, 94901
Withdrawn
Poprad, Slovakia, 05801
Recruiting
Zilina, Slovakia, 01001
Contact: MannKind Investigational Site    6617755300      
Ukraine
Recruiting
Kiev, UA, Ukraine, 04114
Contact: MannKind Investigational Site    6617755300      
Recruiting
Kiev, UA, Ukraine, 04053
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Recruiting
Kyiv, UA, Ukraine, 01021
Contact: MannKind Investigational Site    6617755300      
Withdrawn
Donetsk, UKR, Ukraine, 83003
Withdrawn
Kiev, UKR, Ukraine, 01004
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: August 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Diabetes Mellitus, Type 2
Lung Diseases, Obstructive
Diabetes Mellitus, Type 1
Diabetes Mellitus
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 September 29, 2014