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Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes

NCT00474045 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2017-03-10

Study results available
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Summary

This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart).

Conditions

Interventions

DRUG

insulin detemir

Treat-to-target, dose titration, s.c. (under the skin) injection

DRUG

NPH insulin

Treat-to-target, dose titration, s.c. (under the skin) injection

DRUG

insulin aspart

Treat-to-target, dose titration, s.c. (under the skin) injection

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
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • Croatia
  • Denmark
  • Finland
  • France
  • Ireland
  • Israel
  • Norway
  • Poland
  • Russia
  • South Africa
  • Spain
  • United Kingdom

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 NCT00474045 on ClinicalTrials.gov