Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler

Stopped early · Phase 3

Conditions studied: Type 2 Diabetes

In brief

This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.

Key facts

Study ID

NCT01196104

Run by

Mannkind Corporation

People needed

39

Starts

2010-09-01

Expected to finish

2012-03-01

Last updated by the study team

2014-10-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥ 18 and ≤ 80 years of age
• 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)

You may not qualify if…

• Current or prior treatment with prandial or PreMix (70/30) insulin
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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