EUCTR2007-000634-39-DE进行中（未招募）不适用
Postpartum Intervention in Women with Gestational Diabetes using Insulin - PINGUI
Forschergruppe Diabetes e. V. am Helmholtz Zentrum München0 个研究点开始时间: 2009年3月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Female subjects who are at least 18 years of age, who are less than 7
- •months post-partum, and who had insulin treated GDM during their most
- •recent pregnancy (see 8)
- •2.Written informed consent to participate in the study
- •3.Ability to comply with all study requirements
- •4.Agree with the medication after finishing with breast feeding
- •5.Contraception after the last pregnancy for the next 2 years
- •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.Pregnant or lactating female
- •2.GAD antibody or IA-2 antibody positive
- •3.Diabetes, defined as any of the following (FPG > 126mg/dL (7.0 mmol/L) at visit 1 or 2-hr post-challenge plasma glucose (after a 75-g OGTT) > 200 mg/dL (11.1 mmol/L) or diabetes diagnosed by a physician and confirmed by other clinical data, other than gestational diabetes
- •4.Use of insulin or any oral antidiabetic agents after pregnancy and prior to visit 1
- •5.concomitant use of drugs that affect carbohydrate metabolism
- •6.psychiatric disorders
- •7.history of vein thrombosis
- •8.bleeding disorders by clinical history
- •9.severe maternal or fetal complications during pregnancy
- •10.dietary only treatment during pregnancy
- •11.family planning within the next two years
- •12.Any of the following ECG abnormalities: Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation, second degree AV block (Mobitz 1 and 2), third degree AV block, prolonged QTc (> 500 ms)
- •13.malignancy including leukemia and lymphoma within the last 5 years
- •14.liver disease such as cirrhosis or chronic active hepatitis
- •15.treatment with growth hormone or similar drugs
- •16.chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1
- •17.treatment with class Ia, Ib and Ic or III anti-arrhythmics
- •18.any significant laboratory abnormalities at visit 1
- •19. Any of the following significant laboratory abnormalities
- •ALT, AST > 2 times the upper limit of the normal range (ULN) at visit 1, confirmed by a repeat measure within 3 working days
- •Total bilirubin > 2 times ULN and direct bilirubin > ULN at visit 1, confirmed by a repeat measure within 3 working days
- •20. Participation in another clinical trial within the last 3 months
- •21. Blood loss (e.g. by blood donation) of > 400 ml within the last 2 months
- •22. Any disease or condition which could impair study participation in the opinion of the
- •investigator
研究者
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