drugset / Trial / NCT00424411
Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
To determine, in subjects with Type 2 Diabetes Mellitus: 1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day. 2. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.
Timeline
- Start
- 1999-09
- Primary completion
- —
- Completion
- 2000-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | — | Inhaled |