A Pivotal Long-Term, Open-Label, Parallel Study of the Efficacy and Safety of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus
A Pivotal Long-Term, Open-Label, Parallel Study of the Efficacy and Safety of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
Inclusion Criteria:
Exclusion Criteria:
Sacramento, California, United States
Walnut Creek, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Newark, Delaware, United States
Hollywood, Florida, United States
Jacksonville, Florida 32204, United States
Largo, Florida, United States
New Port Richey, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
North Plainfield, New Jersey 07060, United States
Flushing, New York 11365, United States
Lake Success, New York, United States
New Hyde Park, New York, United States
Staten Island, New York, United States
Morehead City, North Carolina 28557, United States
Raleigh, North Carolina, United States
Medford, Oregon, United States
Downingtown, Pennsylvania, United States
Sellersville, Pennsylvania 34652, United States
Sioux Falls, South Dakota, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Renton, Washington 98055, United States
Milwaukee, Wisconsin 53209, United States
Aalst, Belgium
Arlon, Belgium
Brussels, Belgium
Edegem, Belgium
Leuven, Belgium
Liège, Belgium
Winnipeg, Manitoba, Canada
Corunna, Ontario, Canada
Niagara Falls, Ontario, Canada
Peterborough, Ontario, Canada
Sarnia, Ontario, Canada
Montreal, Quebec, Canada
Zagreb, Croatia
Budapest, Hungary
Debrecen, Hungary
Eger, Hungary
Gyula, Hungary
Kecskemét, Hungary
Nyíregyháza, Hungary
Szeged, Hungary
Szolnok, Hungary
Bangalore, India
Kochi, India
Mumbai, India
New Dehli, India