A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 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 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
Inclusion Criteria:
Exclusion Criteria:
Sacramento, California 95825, United States
Santa Ana, California 92705, United States
Jacksonville, Florida 32204, United States
Miami, Florida 33156, United States
Baton Rouge, Louisiana 70808, United States
Hamilton, New Jersey 08610, United States
Greenville, South Carolina 29605, United States
Ogden, Utah 84403, United States
Charleston, West Virginia 25304, United States
Fortaleza, 60120-020, Brazil
Porto Alegre, 90035-003, Brazil
São Paulo, 04020041, Brazil
Berlin, 10115, Germany
Dresden, 01307, Germany
Erlangen, 91054, Germany
Frankfurt, 60596, Germany
Leipzig, D-04103, Germany
Mainz, D-55116, Germany
Budapest, H-1139, Hungary
Makó, 6900, Hungary
Veszprém, 8200, Hungary
Zalaegerszeg, 8900, Hungary
Bangalore, 560010, India
Mumbai, 400 007, India
Pune, 411005, India
Catania, 95100, Italy
Genova, 16132, Italy
Milan, 20132, Italy
Pisa, 56100, Italy
Rome, 00168, Italy
Mexico City, 06700, Mexico
Monterrey, 64410, Mexico
Katowice, 40-044, Poland
Lublin, 20-954, Poland
Oleśnica, Poland
Coimbra, 3000-076, Portugal
Lisbon, 1250-203, Portugal
Manati, 00674, Puerto Rico
San Juan, 00907, Puerto Rico
Yabucoa, 00767, Puerto Rico
Changhua, 500, Taiwan
Neihu Taipei, 114, Taiwan
Yungkang City, 710, Taiwan