drugset / Trial / NCT00424437

Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.

NCT00424437

Phase 3 Completed 320 enrolled Pfizer
RandomizedParallel-groupOpen-labelTreatment

Summary

To determine, in subjects with Type 1 Diabetes Mellitus: 1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin injections per day. 2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.

Timeline

Start
1999-09
Primary completion
Completion
2000-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic Inhaled