Efficacy and Safety of Insulin Aspart vs. Human Insulin During Pregnancy by Women With Type 1 Diabetes

NCT00365170 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2016-12-21

No results posted yet for this study

Summary

This trial was conducted in Europe, Middle East, North America and South America.

The aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.

Conditions

Interventions

DRUG

human insulin

DRUG

insulin aspart

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (1452, GCR) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2005-04-30
Completion
2005-04-30

Countries

  • Argentina
  • Austria
  • Bulgaria
  • Canada
  • Croatia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Israel
  • Netherlands
  • Norway
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

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Entities

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 NCT00365170 on ClinicalTrials.gov