Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler
NCT ID: NCT01196104
Last Updated: 2014-10-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
39 participants
INTERVENTIONAL
2010-09-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Technosphere® Insulin Inhalation Powder (TI)
Insulin Glargine and Technosphere® Insulin Inhalation Powder
Technosphere® Insulin Inhalation Powder
Insulin Glargine
Comparator
Insulin Glargine and Insulin Aspart
Insulin Aspart
Usual Care
Insulin Glargine
Interventions
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Technosphere® Insulin Inhalation Powder
Insulin Aspart
Usual Care
Insulin Glargine
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
* Body mass index (BMI) ≤ 45 kg/m2
* Glycated Hemoglobin (HbA1c) \> 6.5% and ≤ 10.0%
* Treatment with 1 to 3 Oral Antidiabetic Drugs (OADs) and basal insulin for a minimum of 3 months before screening. Doses of OADs must have been stable for 3 months before study entry
* Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding ≥ 6 months
* Office spirometry at the investigator site
* Forced expiratory volume in 1 second (FEV1) ≥ 65% Third National Health and Nutrition Examination Survey (NHANES III) predicted
* Forced vital capacity (FVC) ≥ 65% NHANES III predicted
* Forced expiratory volume in 1 second as a percentage of forced vital capacity (FEV1/FVC) ≥ lower limit of normal (LLN)
Exclusion Criteria
* History of insulin pump use within 6 weeks of Visit 1
* Treatment with Glucagon-like Peptide (GLP-1) analog drugs within the preceding 12 weeks of Visit 1
* History of chronic obstructive pulmonary disease (COPD), asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
* Any clinically significant radiological findings on screening chest x-ray
* Use of medications for asthma, COPD, or any other chronic respiratory conditions
* Evidence of serious complications of diabetes (eg, symptomatic autonomic neuropathy)
* Significant cardiovascular dysfunction or history within 3 months of Visit 1 (eg, congestive heart failure \[New York Heart Association {NYHA} Class III or IV\])
* Serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or any cerebrovascular accident
* History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening (Visit 1)
18 Years
80 Years
ALL
No
Sponsors
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Mannkind Corporation
INDUSTRY
Responsible Party
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Locations
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Coastal Clinical Research Inc
Mobile, Alabama, United States
Valley Research
Fresno, California, United States
Health Care Partners Medical Group
Long Beach, California, United States
Diabetes Research Center
Tustin, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Laureate Clinical Research Group
Atlanta, Georgia, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Alta Pharmaceutical Research Center
Dunwoody, Georgia, United States
John H Stoger Jr Hospital of Cook County
Chicago, Illinois, United States
LaPorte County Institute for Clinical Research Inc.
Michigan City, Indiana, United States
Radiant Research Inc (Minneapolis)
Edina, Minnesota, United States
Amin Radparvar's Private Practice
City of Saint Peters, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Billings Clinic Research Center
Billings, Montana, United States
Creighton Diabetes Center
Omaha, Nebraska, United States
University of New Mexico HCS
Albuquerque, New Mexico, United States
Winthrop University Hospital
Mineola, New York, United States
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, United States
Endocrine Research Physicians East PA
Greenville, North Carolina, United States
Your Diabetes Endocrine Nutrition Group, Inc.
Mentor, Ohio, United States
Legacy Clinical Research
Portland, Oregon, United States
OHSU Diabetes Center Research Oregon Health & Science University
Portland, Oregon, United States
The Endocrine Clinic
Memphis, Tennessee, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
Baylor Endocrine Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
SAM Clinical Research Center
San Antonio, Texas, United States
Exodus Healthcare Network
Magna, Utah, United States
Diabetes Research Center -Fletcher Allen Health Care
South Burlington, Vermont, United States
Countries
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Other Identifiers
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MKC-TI-162
Identifier Type: -
Identifier Source: org_study_id
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