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Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

NCT01045707 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2016-12-08

Study results available
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Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug).

The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.

Conditions

Interventions

DRUG

insulin degludec/insulin aspart

Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.

DRUG

insulin glargine

Injected s.c. (under the skin) once daily. Dose was individually adjusted.

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
2010-01-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States
  • Austria
  • India
  • Poland
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Turkey (Türkiye)

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 NCT01045707 on ClinicalTrials.gov