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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: NPH insulin; Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00474045

NN304-1687

2006-004861-33 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 470 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes treated with insulin for at least 12 months
• Planning to become pregnant and have a screening HbA1c (glycosylated haemoglobin) lesser than or equal to 9.0%, or
• Pregnant with an intrauterine singleton living foetus, 8-12 weeks pregnant when joining the trial and a HbA1c lesser than or equal to 8.0% when pregnancy is confirmed

Exclusion criteria

• Known or suspected hypersensitivity to the trial product(s) or related products
• Untreated hyperthyroidism or hypothyroidism
• Known or suspected abuse of alcohol or narcotics
• Cardiac problems
• Impaired kidney function
• History of severe hyperemesis gravidarum
• Treatment with in-vitro fertilisation or other medical infertility treatment
• Impaired liver function
• Uncontrolled hypertension
• Proliferative retinopathy or maculopathy requiring acute treatment
• Known to be HIV (human immunodeficiency virus) positive, Hepatitis B or Hepatitis C positive
• Any concomitant medication contraindicated in pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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470 participants in 2 patient groups

Insulin detemir

Experimental group

Description:

Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn

Treatment:

Drug: insulin aspart

Drug: insulin detemir

Neutral Protamine Hagedorn (NPH) insulin

Active Comparator group

Description:

Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn

Treatment:

Drug: insulin aspart

Drug: NPH insulin