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Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes

NCT00613951 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2017-03-20

Study results available
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Summary

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \[SIAC\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Conditions

Interventions

DRUG

insulin degludec/insulin aspart

Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

DRUG

insulin degludec/insulin aspart

Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

DRUG

biphasic insulin aspart

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

DRUG

metformin

Tablets, 1500-2000 mg/daily

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
2008-08-31
Completion
2008-08-31

Countries

  • Finland
  • France
  • Germany
  • Poland
  • 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 NCT00613951 on ClinicalTrials.gov