Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes
Trial end date:
SummaryTo 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.
Accepts Healthy Volunteers?No
Insulin, Globin Zinc
- Type 2 Diabetes
- Stable insulin regimen of at least 2 injections per day
- Any smoking within the last 6 months. Smoking is not permitted at any time during this
- Subjects on insulin pump during 2 months prior to screening.
- Subjects with poorly-controlled asthma, clinically significant chronic obstructive
pulmonary disease, or other significant respiratory disease.