drugset / Trial / NCT00424411

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

NCT00424411

Phase 3 Completed 300 enrolled Pfizer
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

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic Inhaled