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Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes

NCT00469586 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2017-03-01

No results posted yet for this study

Summary

This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

Conditions

Interventions

DRUG

inhaled human insulin

Treat-to-target dose titration scheme, pre-prandial, inhalation.

DRUG

metformin

Tablets, 2000 mg/day.

DRUG

glimepiride

Tablets, 4 mg/day.

DRUG

inhaled human insulin

Treat-to-target dose titration scheme, post-prandial, inhalation.

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
2007-04-26
Primary Completion
2008-04-24
Completion
2008-04-24

Countries

  • Argentina
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • France
  • India
  • Israel
  • Mexico
  • Poland
  • Turkey (Türkiye)

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 NCT00469586 on ClinicalTrials.gov