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Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

NCT00331604 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 618

Last updated 2017-03-01

No results posted yet for this study

Summary

This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 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.

DRUG

insulin aspart

Treat-to-target dose titration scheme, injection s.c. After 2 years.

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
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-05-05
Completion
2008-05-05

Countries

  • Brazil
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Israel
  • Italy
  • Singapore
  • Spain
  • Taiwan
  • United Kingdom

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 NCT00331604 on ClinicalTrials.gov