A Randomised Placebo Controlled Trial of the effectiveness of Early MEtformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE)

ational University of ireland Galway0 sites535 target enrollmentAugust 10, 2016

Overview

No summary available.

Registry

who.int

Start Date

August 10, 2016

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

ational University of ireland Galway

•Inclusion Criteria:
•a)Willing and able to provide written informed consent
•b)Participants aged 18\-50 years
•c)Pregnancy gestation up to 28 weeks (\+ 6 days) confirmed by positive pregnancy test
•d)Singleton pregnancy as determined by scan
•e)Positive diagnosis of Gestational Diabetes Mellitus on a OGTT according to IADPSG criteria if any one of the following are achieved:
•a.Fasting glucose \>/\= 5\.1mmol/l and \<7mmol/l, or
•b.1 hour post glucose load of \>/\=10mmol/l, or
•c.2 hour post glucose load of \>/\=8\.5 mmol/l and \<11\.1mmol/l
•f)Resident in the locality and intending to deliver within the trial site

•Exclusion Criteria:
•Women who meet any one or more of the following exclusion criteria will not be eligible to take part in the trial:
•a)Participants who have an established diagnosis of diabetes (Type 1, Type 2, Monogenic or secondary)
•b)Participants with a fasting glucose \= 7mmol/l or a 2h value \= 11\.1 mmol/l
•c)Multiple pregnancies (twins, triplets etc.) as determined by scan
•d)Known intolerance to metformin
•e)Known contraindication to the use of metformin which include:
•i.renal insufficiency (defined as serum creatinine of greater than 130 µmol/L or creatinine clearance \<60 ml/min)
•ii.moderate to severe liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of normal)
•iii.shock or sepsis, and