Overview

Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes

Status:
Completed
Trial end date:
2000-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Insulin
Insulin, Globin Zinc
Criteria
Inclusion Criteria:

- Type 2 Diabetes

- Stable insulin regimen of at least 2 injections per day

Exclusion Criteria:

- Any smoking within the last 6 months. Smoking is not permitted at any time during this
study.

- 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.