Status: Finalised First registered on: 13/07/2017
Last updated on: 17/05/2022
1. Study identification
EU PAS Register NumberEUPAS19686
Official titleConsequences for life of children with in utero exposure to metformin in Finland – a register-based cohort study
Study title acronymCLUE
Study typeObservational study
Brief description of the studyMetformin is used during pregnancy to treat hyperglycaemia in gestational diabetes mellitus (GDM) and pre-gestational diabetes (PGDM), and to treat the polycystic ovary syndrome (PCOS). Despite the use of metformin during pregnancy in these three conditions, the long-term effects of metformin exposure in utero have not been widely studied in the children beyond two years of age. Evidence on these effects is of major interest, as metformin crosses the placenta and might therefore have long-term effect on the children. Using population-level data from Finland, this study will provide information on these long-term effects among children of women who used metformin during pregnancy. The aim of this study is to investigate the long-term and immediate effects of exposure to metformin in utero among the children of all pregnant women treated with metformin, regardless of the purpose of use. The long-term effects include e.g. diagnoses of obesity, hypo- and hyperglycaemia, diabetes mellitus, diagnoses related to challenges in motor-social development, and growth-related outcomes. In addition, immediate effects of exposure to metformin in utero will be investigated, including growth outcomes at birth, preterm birth, perinatal mortality, hypo- and hyperglycaemia at birth, and major congenital anomalies. The long-term effects described above in the children of women pregnant from 1996 onwards and treated during their pregnancy with metformin only, or with a combination of insulin and metformin, will be compared to the children of pregnant women treated during their pregnancy with insulin only. Additionally, and making use of the availability of GDM diagnosis data from 2004 onwards, a cohort of children born to mothers with GDM and naïve to in utero exposure to pharmacological antidiabetic treatment will be added for comparison.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA
Department/Research groupIQVIA Global Database Studies
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Dr
Last name Toussi
First name Massoud
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Finland
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/02/2017
Start date of data collection05/11/201830/11/2018
Start date of data analysis31/12/201830/11/2018
Date of interim report, if expected
Date of final study report31/12/202004/08/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMerck KGaA100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Korhonen
First name Pasi
Address line 1Global Database Studies, IQVIA
Address line 2Spektri, Duo Building, Metsänneidonkuja 6 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358408643912 
Alternative phone number 
Fax number (incl. country code) 
Email address ENCePP@iqvia.com
Public Enquiries
Title Ms 
Last name Hetemäki 
First name Saara 
Address line 1Global Database Studies, IQVIA 
Address line 2Spektri, Duo Building, Metsänneidonkuja 6 
Address line 3 
CityEspoo 
PostcodeFI-02130 
CountryFinland 
Phone number (incl. country code)358-40-7241592 
Alternative phone number 
Fax number (incl. country code) 
Email address ENCePP@iqvia.com 
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