Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | July 2005 |
| End Date: | May 2008 |
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.
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:
- Type 1 diabetes
- Non smoker
- Normal lung function
Exclusion Criteria:
- Significant pulmonary, hepatic, or renal disease
- Severe congestive heart failure
- Active malignancy
- Systemic glucocorticoid therapy
We found this trial at
36
sites
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