NCT00365170|CompletedPhase 4

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

A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

ANA-1474

Study Type

interventional

Target

419

Locations

18 countries

Sites

Timeline

RegisteredAug 2006

StartedSep 2002

CompletionApr 2005

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

419

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Sep 2002

Typical duration for phase_4 diabetes

Geographic Reach

18 countries

95 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

Study Start

First participant enrolled

September 1, 2002

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed

1.4 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed

7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed

Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

2.6 years

First QC Date

August 10, 2006

Last Update Submit

December 20, 2016

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Relative risk of major maternal hypoglycaemia
after 24 hours

Secondary Outcomes (4)

Relative risk of major and minor hypoglycaemia
Diabetic complications
Obstetric complications
Other Adverse Events

Interventions

human insulinDRUG

insulin aspartDRUG

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 1 diabetes
Treated with insulin for at least 12 months
Either plan to become pregnant in the immediate future, willing to undertake pre pregnancy counselling, and has a screening HbA1c lesser than or equal to 12.0%, or
Pregnant with normal singleton pregnancy, gestational age for at least 10 weeks at the time of randomisation, confirmed by ultrasound scan.

You may not qualify if:

Previous birth of child with a major congenital malformation
More than 2 previous multiple miscarriages or stillbirths
Severe hyperemesis gravidarum, requiring hospitalisation, according to Investigator judgement
Subjects being treated for infertility
Proliferative retinopathy or maculopathy requiring acute treatment
Drug or alcohol abuse
Impaired renal, hepatic or cardiac function

Contact the study team to confirm eligibility.