Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

Completed · Phase 3

Conditions studied: Diabetes, Type I

In brief

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Key facts

Study ID

NCT00308308

Run by

Mannkind Corporation

People needed

589

Starts

2006-02-01

Expected to finish

2008-08-01

Last updated by the study team

2014-10-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Clinical diagnosis of type 1 diabetes for at least 1 year
• Nonsmokers for prior 6 months
• BMI less than or equal to 35kg/m2
• HbA1c > or = 7% and < or = 11%
• Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects
• FEV1 > or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted
• Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
• Urine cotinine < or = 100 ng/mL

You may not qualify if…

• History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings
• Evidence of severe complications of diabetes
• Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal

Where it is running

• Radiant Research (Phoenix) — Chandler, Arizona, United States
• International Clinical Research Network — Chula Vista, California, United States
• Family Medical Center — Foothill Ranch, California, United States
• Diabetes/Lipid Management and Research Center — Huntington Beach, California, United States
• South Bay Clinical Research — Inglewood, California, United States
• Radiant Research — San Diego, California, United States
• Coastal Biomedical Research Inc — Santa Monica, California, United States
• Diabetes Research Center — Tustin, California, United States
• International Research Associates LLC — Miami, Florida, United States
• Laureate Clinical Research Group — Atlanta, Georgia, United States
• Atlanta Pharmaceutical Research Center — Dunwoody, Georgia, United States
• North Atlanta Endocrinology & Diabetes PC — Lawrenceville, Georgia, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• John H Stoger Jr Hospital of Cook County — Chicago, Illinois, United States
• Clintell Inc — Skokie, Illinois, United States
• Medical Research of Louisiana — Metairie, Louisiana, United States
• Oschner Clinic Foundation — New Orleans, Louisiana, United States
• James A Dicke MDPA — Towson, Maryland, United States
• Wayne State University — Detroit, Michigan, United States
• Hurley Medical Center — Flint, Michigan, United States
• Michigan Institute of Medicine — Livonia, Michigan, United States
• KMED Research — Saint Clair Shores, Michigan, United States
• Radiant Research Inc (Minneapolis) — Edina, Minnesota, United States
• International Diabetes Center — Minneapolis, Minnesota, United States
• Coastal Clinical Research Inc — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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