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Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

NCT00348712 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2017-03-01

No results posted yet for this study

Summary

This trial is conducted in Europe.

The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

Conditions

Interventions

DRUG

rosiglitazone

Tablets, 4 mg once or twice daily.

DRUG

inhaled human insulin

Treat-to-target dose titration scheme, inhalation.

DRUG

metformin

Tablets, 2000 mg/day.

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
2006-10-30
Primary Completion
2008-03-05
Completion
2008-03-05

Countries

  • Austria
  • Finland
  • France
  • Germany
  • Ireland
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00348712 on ClinicalTrials.gov