MedTrace Logo

Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

NCT00614055 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2017-03-20

Study results available
· View outcomes & findings →

Summary

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Conditions

Interventions

DRUG

insulin degludec/insulin aspart

Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily

DRUG

insulin degludec/insulin aspart

Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily

DRUG

insulin glargine

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

DRUG

metformin

Tablets, 1500-2000 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
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • France
  • Germany
  • Norway
  • Romania
  • Spain

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 NCT00614055 on ClinicalTrials.gov