Type 1 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 only: willingness to discontinue any concomitant medication, e.g. certain anti-hypertensives, like ACE-inhibitors, contraindicated in pregnancy according to local labelling prior to conception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Known or suspected hypersensitivity to the trial product(s) or related products 2.Previous randomisation in this trial 3.Untreated hyper or hypothyroidism 4.Known or suspected abuse of alcohol or narcotics 5.Cardiac problems as evaluated by either: a.Cardiac failure or b.Diagnosis of unstable angina pectoris or c.Previous myocardial infarction 6.Impaired renal function as evaluated by any of the following: a.Diagnosis of diabetic nephropathy b.S-creatinine =125 µmol/L c.Macro-albuminuria, as evaluated by U-albumin:Creatinine ratio > 300 mg/g in random spot urine sample 7.History of severe hyperemesis gravidarum (requiring hospitalisation) according to Investigator judgement 8.Subject being treated or became pregnant with assistance of in-vitro fertilisation or other medical infertility treatment 9.Receipt of any investigational drug within 3 months prior to screening for this trial 10.Impaired hepatic function as evaluated by alanine aminotransferase, or alkaline phosphatase = two times the upper reference limit 11.Uncontrolled hypertension (systolic BP =140 mmHg and/or Diastolic BP = 90 mmHg) in the supine position 12.Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation 13.Proliferative retinopathy or maculopathy requiring acute treatment 14.Any disease or condition which the investigator feels would interfere with the trial, e.g. clinically significant gynaecological conditions 15.Known to be HIV positive 16.Known to be Hepatitis B or C positive 17.Any concomitant medication, e.g. certain anti-hypertensives like ACE-inhibitors, contraindicated in pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Austria, Finland, France, Ireland, Spain, United Kingdom
Outcome results
None listed