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Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes

NCT01009580 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 447

Last updated 2018-12-19

Study results available
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Summary

This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.

Conditions

Interventions

DRUG

insulin degludec/insulin aspart

Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.

DRUG

biphasic insulin aspart 30

Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.

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
2009-11-05
Primary Completion
2010-08-23
Completion
2010-08-23

Countries

  • Australia
  • Denmark
  • Finland
  • India
  • Malaysia
  • Poland
  • Sweden
  • Taiwan
  • Thailand
  • 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 NCT01009580 on ClinicalTrials.gov