EUCTR2006-004861-33-DK进行中（未招募）1 期
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 diabetesTrial Phase: 3b
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 460
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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.
研究者
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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 diabetesTrial Phase: 3bType 1 diabetesMedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusEUCTR2006-004861-33-IEovo Nordisk A/S407
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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 diabetesTrial Phase: 3bMedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusType 1 diabetesEUCTR2006-004861-33-GBovo Nordisk A/S460
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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 diabetesTrial Phase: 3bMedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusType 1 diabetesEUCTR2006-004861-33-ATovo Nordisk A/S460
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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 diabetesTrial Phase: 3bType 1 diabetesMedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusEUCTR2006-004861-33-FRovo Nordisk A/S
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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 diabetesTrial Phase: 3bType 1 diabetesEUCTR2006-004861-33-FIovo Nordisk A/S460