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

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 whenjoining 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 Cpositive

• Any concomitant medication contraindicated in pregnancy