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

This study has been terminated.
(Poor enrollment)
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00642616
First received: March 21, 2008
Last updated: October 15, 2014
Last verified: October 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 ]

Enrollment: 24
Study Start Date: June 2008
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: November 2014 (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

  Hide Study Locations
Locations
United States, Arizona
Flagstaff, Arizona, United States, 86001
United States, California
El Cajon, California, United States, 92020
Fresno, California, United States, 93726
Fresno, California, United States, 93720
Long Beach, California, United States, 90806
Los Alamitos, California, United States, 90720
Mission Hills, California, United States, 91345
San Diego, California, United States, 92117
San Diego, California, United States, 92114
United States, Florida
Brandon, Florida, United States, 33511
Clearwater, Florida, United States, 33756
Coral Gables, Florida, United States, 33134
Hollywood, Florida, United States, 33024
Miami, Florida, United States, 33136
Miami, Florida, United States, 33155
Miami, Florida, United States, 33165
Miami, Florida, United States, 33144
Miami, Florida, United States, 33142
Miami, Florida, United States, 33186
New Port Richey, Florida, United States, 34652
Orlando, Florida, United States, 32804
Pembroke Pines, Florida, United States, 33028
Pinellas Park, Florida, United States, 33782
United States, Georgia
Atlanta, Georgia, United States, 30308
Atlanta, Georgia, United States, 30329
United States, Illinois
Chicago, Illinois, United States, 60607
United States, Indiana
Michigan City, Indiana, United States, 46360
United States, Louisiana
Metairie, Louisiana, United States, 70002
United States, Maryland
Annapolis, Maryland, United States, 21401
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Waltham, Massachusetts, United States, 02453
United States, Michigan
Flint, Michigan, United States, 48503
Flint, Michigan, United States, 48504
United States, Missouri
St. Louis, Missouri, United States, 63141
United States, Montana
Billings, Montana, United States, 59101
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Bayside, New York, United States, 11361
New Hyde Park, New York, United States, 11042
New York, New York, United States, 10022
New York, New York, United States, 10032
United States, North Carolina
Charlotte, North Carolina, United States, 28207
Greenville, North Carolina, United States, 27834
Morehead City, North Carolina, United States, 28557
United States, Oregon
Medford, Oregon, United States, 97504
United States, Pennsylvania
Downingtown, Pennsylvania, United States, 19335
United States, South Carolina
Greenville, South Carolina, United States, 29615
Greer, South Carolina, United States, 29651
Rock Hill, South Carolina, United States, 29732
Spartanburg, South Carolina, United States, 29302
Spartanburg, South Carolina, United States, 29303
United States, Texas
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78731
Dallas, Texas, United States, 75225
Dallas, Texas, United States, 75218
Dallas, Texas, United States, 75231
Georgetown, Texas, United States, 78626
Irving, Texas, United States, 75039
North Richland Hills, Texas, United States, 76180
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78249
Tomball, Texas, United States, 77375
United States, Utah
Magna, Utah, United States, 84044
United States, Washington
Federal Way, Washington, United States, 98003
Tacoma, Washington, United States, 98405
United States, Wisconsin
Kenosha, Wisconsin, United States, 53142
Argentina
Mar del Plata, Buenos Aires, Argentina, B7602DCK
Mar del Plata, Buenos Aires, Argentina, 7600
Buenos Aires, Argentina, C1425AGC
Buenos Aires, Argentina, 1425
Buenos Aires, Argentina, C1120AAC
Buenos Aires, Argentina, C1425DES
Buenos Aires, Argentina, C1419AHN
Mendoza, Argentina, 5500
Brazil
Fortaleza, Ceara, Brazil, 60115-282
Fortaleza, Ceará, Brazil, 60430-370
Belem, Para, Brazil, 66073-000
Porto Alegre, RS, Brazil, 90035-170
Campinas, Sao Paulo, Brazil, 13073-350
Mogi das Cruzes, Sao Paulo, Brazil, 08780-090
Santo André, Sao Paulo, Brazil, 09060-650
Sao Jose, Sao Paulo, Brazil, 15090-000
São Bernardo do Campo, Sao Paulo, Brazil, 09780-000
Porto Alegre, Brazil, 91350-250
Sao Paulo, Brazil, 01244-030
Sao Paulo, Brazil, 05403-900
Chile
Santiago, Chile
Santiago, Chile, 8330008
Santiago, Chile, 7850000
Viña del Mar, Chile, 2520000
Germany
Aschaffenburg, Bayern, Germany, 63739
Berlin, DEU, Germany, D 10115
Frankfurt, Hessen, Germany, 60596
Essen, Nordrhein Westfalen, Germany, 45355
Goch, Nordrhein Westfalen, Germany, 47574
Hungary
Budapest, Hungary, 1033
Budapest, Hungary, 1145
Russian Federation
Moscow, Russia, Russian Federation, 125367
Moscow, RUS, Russian Federation, 107150
Yaroslavl, RUS, Russian Federation, 150002
Kemerovo, RU, Russian Federation, 650066
Moscow, RU, Russian Federation, 117036
Moscow, RU, Russian Federation, 105120
Moscow, RU, Russian Federation, 121374
Moscow, RU, Russian Federation, 129128
St Petersburg, RU, Russian Federation, 194291
St Petersburg, RU, Russian Federation, 198013
St. Petersburg, RU, Russian Federation, 191186
St. Petersburg, RU, Russian Federation, 194354
St. Petersburg, RU, Russian Federation, 191015
St. Petersburg, RU, Russian Federation, 191119
Yaroslavl, RU, Russian Federation, 150003
Slovakia
Liptovsky Hradok, Slovakia, 03301
Martin, Slovakia, 03659
Zilina, Slovakia, 01001
Ukraine
Kiev, UA, Ukraine, 04114
Kiev, UA, Ukraine, 04053
Kyiv, UA, Ukraine, 01021
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: October 15, 2014
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Autoimmune Diseases
Bronchial Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Metabolic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014