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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Detemir; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting; Isophane insulin, beef; Isophane Insulin, Human; Protamines

Criteria

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