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Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

NCT00978627 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 548

Last updated 2017-03-20

Study results available
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Summary

This trial is conducted in Europe, Oceania, and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.

Conditions

Interventions

DRUG

insulin degludec/insulin aspart

Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.

DRUG

insulin detemir

Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted.

DRUG

insulin aspart

Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted.

DRUG

insulin aspart

Injected subcutaneously (under the skin) as meal time insulin. 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
2009-08-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • Australia
  • Denmark
  • France
  • Israel
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • United Kingdom

Study Locations

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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 NCT00978627 on ClinicalTrials.gov