A randomised, parallel-group, open-labelled, multinational trial comparing the efficacy and safety of insulin detemir (Levemir®) versus human insulin (NPH insulin), used in combination with insulin aspart as bolus insulin, in the treatment of pregnant women with type 1 diabetes Trial Phase: 3b

INTERVENTION: Trade Name: Levemir Pharmaceutical Form: Solution for injection INN or Proposed INN: Insulin detemir Current Sponsor code: NN304 Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 100‐ Trade Name: NovoRapid Pharmaceutical Form: Solution for injection INN or Proposed INN: Insulin aspart Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 100‐ Trade Name: Insulatard Pharmaceutical Form: Solution for injection INN or Proposed INN: Insulin human Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100‐ CONDITION: Type 1 diabetes ; MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus PRIMARY OUTCOME: Main Objective: To compare the glycaemic control measured as HbA1c obtained by using either insulin detemir or NPH insulin at gestational week (GW) = 36 (P4). Primary end point(s): HbA1c at GW=36 (P4) Secondary Objective: Efficacy objectives; To compare the two treatments with respect to: ; •HbA1c during the pregnancy period; •Number of subjects with HbA1c = 6.0% both at GW=24 (P3) and GW=36 (P4) ; •8‐point self‐measured plasma glucose (SMPG) profiles during the pregnancy period ; •Fasting plasma glucose (FPG) values during the pregnancy period; ; For safety objectives (maternal and pregnancy outcome) please see protocol section 1.; INCLUSION CRITERIA: 1.The subject must give informed consent before any trial related activities. (Trial related activities are any procedures that would not have been performed during the normal management of the subject) 2.Female, age = 18 years 3.Type 1 diabetes treated with insulin (any regimen) for at least 12 months before randomisation 4.The subject is either a.Planning to become pregnant in the immediate future and willing to undertake pregnancy counselling and a screening HbA1c = 9.0% (NGSP) or b.Pregnant with an intrauterine singleton living foetus, GW= 8 ‐12 at randomisation, confirmed by a US scan and an HbA1c = 8.0% at confirmation of pregnancy 5.The subject must be willing to adhere to the procedures specified in the protocol, including 8‐point SMPG measurements 6.Willingness to take (or, if pregnant at screening, have taken) folic acid before pregnancy and during the first trimester according to local guidelines 7.For non‐pregnant subjects o