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Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

NCT01074268 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2017-03-06

Study results available
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Summary

This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (\[Deg\]) with insulin detemir (IDet), both combined with insulin aspart.

The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.

Conditions

Interventions

DRUG

insulin degludec

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

DRUG

insulin detemir

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

DRUG

insulin aspart

Injected s.c. (under the skin) as mealtime 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
2010-02-28
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Argentina
  • Brazil
  • Finland
  • India
  • Italy
  • Japan
  • North Macedonia
  • 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 NCT01074268 on ClinicalTrials.gov