MedTrace Logo

Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

NCT00322257 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2018-09-05

No results posted yet for this study

Summary

This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes.

Conditions

Interventions

DRUG

inhaled human insulin

Treat-to-target dose titration scheme, inhalation.

DRUG

insulin detemir

Injection s.c., 50% of daily dose

DRUG

insulin aspart

Treat-to-target dose titration scheme, injection s.c.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-01
Primary Completion
2008-04-02
Completion
2008-04-02

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00322257 on ClinicalTrials.gov