Last reviewed · How we verify
A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma
Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month follow up period.
Details
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 299 |
| Start date | 2005-08 |
| Completion | 2008-05 |
Conditions
- Diabetes Mellitus
- Asthma
- Pulmonary Disease, Chronic Obstructive
Interventions
- Human Insulin Inhalation Powder
- injected insulin
Primary outcomes
- To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c. — 12 months
Countries
United States, Argentina, Bulgaria, Canada, Chile, Colombia, Croatia, Hong Kong, Hungary, India, Mexico, Philippines, Puerto Rico, Singapore, Taiwan, Thailand