E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pregnancy of a women dealing with type 1 diabetes
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Tyypin 1 diabeetikon raskaus |
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E.1.1.1 | Medical condition in easily understood language |
Pregnancy of a women dealing with type 1 diabetes |
Tyypin 1 diabeetikon raskaus |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012594 |
E.1.2 | Term | Diabetes |
E.1.2 | System Organ Class | 100000004861 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of the study is to find out weather metformin ease insulin resistance during pregnancy in women deling with type 1 diabetes. The first endpoint of the study is the reduction of insulin requirement for more than 15% between the metformin and placebo group.
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Tutkimuksen tarkoituksena on selvittää voidaanko metformiinihoidolla helpottaa raskaudenaikaista insuliiniresistenssiä tyypin 1 diabeetikoilla. 1. päätetapahtuma on insuliinin tarpeen vähentyminen yli 15 %:lla metformiinihoidetussa ryhmässä. |
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E.2.2 | Secondary objectives of the trial |
The secondary endpoints are to demonstrate if metformin improves pregnancy prognosis by reducing the number of macrosomic and frail newborns, and reduce the risk of pregnancy and delivery complications and whether it improves maternal blood glucose level.
Pregnancy complications include pre-eclampsia, gestational hepatosis, worsening proteinuria, fetal macrosomia, fetal growth retardation, intrauterine fetal death and premature deliveries. To describe labor results and complications as the percentages of cesarean sections (elective and emergent), vacuum extractions, spontaneous deliveries, shoulder dystocias, lacerations of third and fourth degree and blood loss during labor are collected.
Morbities of the newborns are described by birth weight, Apgar scores, umbilical artery pH, gestational weeks at birth, NICU transmissions, the incidence of hypoglycemia and other major problems of neonatal period. |
Tutkimuksen toissijaisena tavoitteena on selvittää parantaako metformiinihoito raskauden sokeritasapainoa, parantaako hoito raskauden ennustetta vähentämällä makrosomisten ja huonokuntoisten vastasyntyneiden määrää, sekä vähentääkö hoito raskaus- ja synnytyskomplikaatioita.
Raskauskomplikaatioiden suhteen verrataan mm. liitännäispre-eklampsian, raskaushepatoosin, proteinurian, sikiön makrosomian, sikiön kasvunhidastuman, kohdunsisäisten sikiökuolemien ja ennenaikaisten synnytysten esiintymistä.
Synnytysten osalta verrataan synnytystapaa ja raskauden kestoa.
Vastasyntyneistä osalta verrataan syntymäpainoja, kuntoisuutta, teho-osastolle siirtyneiden määrää, hoitoa vaatineiden hypoglykemioiden ja muiden ongelmien esiintymistä. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The use of a new 3/4D ultrasound technology -fractional thigh volume- to detect fetal macrosomia in pregnancy complicated with type 1 diabetes.
Courses of the inflammatory markers that reflect insulin resistance in diabetic pregnancy comparing placebo and metformin treated group.
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Uuden 3/4 ultraäänitekniikan -reiden volyymimittaus- käyttö sikiön makrosomian tunnistamisessa tyypin 1 diabeetikoiden raskauksissa.
Insuliiniresistenssiä kuvaavien inflammatorisen markkereiden kulku tyypin 1 diabeetikoiden raskauksissa metformiini- ja placebohoidettujen ryhmissä.
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E.3 | Principal inclusion criteria |
A pregnancy of a women dealing with type 1 diabetes.
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Tyypin 1 diabeetikon raskaus. |
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E.4 | Principal exclusion criteria |
Exclusion criteria for the study are a twin pregnancy, another significant underlying disease, severe complications of diabetes, substance abuse problems, smoking, underweight or strong early pregnancy nausea.
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Poissulkukriteerejä tutkimuksessa ovat monikkoraskaus, muu merkittävä perussairaus (sepelvaltimotauti, siirtomunuainen, krooniset maksasairaudet, IBD, SLE tai toistuvia oraalisia kortisonikuureja vaativa astma tai reumasairaus), vaikea diabeteksen lisäsairaus (nefropatia: cUAlb˃200µg/min, UAlbkre˃30/mmol tai GFR˂60 ml/min, proliferatiivinen retinopatia tai diabeettinen gastropareesi), päihdeongelma, tupakointi, alipaino (BMI <18) tai voimakas alkuraskauden pahoinvointi. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Ensisijaisena päätetapahtumana on insuliinin tarpeen väheneminen. |
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E.5.2 | Secondary end point(s) |
Toissijaisena tavoitteena on selvittää parantaako metformiinihoito raskauden sokeritasapainoa ja veren lipidiprofiilia ja vaikuttaako hoito verenkierron inflammaatiomarkkereihin. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |