A Clinical Trial of Metformin Versus Placebo for the Treatment of High Blood Sugars During Pregnancy

Phase 1

• Conditions: Gestational Diabetes Mellitus; MedDRA version: 21.1Level: LLTClassification code 10018210Term: Gestational diabetes mellitusSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-001644-19-IE
• Lead Sponsor: ational University of ireland Galway

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-10
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 535

Inclusion Criteria

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

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 535
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
iv.previous hypersensitivity to metformin
f)Major congenital malformations or an abnormality deemed unsuitable for metformin by the site PI or attending consultant
g)Known small for gestational age1
h)Known current gestational hypertension, pre-eclampsia, or ruptured membranes
i)Participants who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
j)Participants with significant gastrointestinal problems such as severe vomiting, Crohn’s disease or colitis which will inadvertently affect absorption of the study drug
k)Participants with congestive heart failure or history of congestive heart failure
l)Participants with serious mental illness which would affect adherence to study medication or compliance with study protocol in the opinion of the investigator
m)Women with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

1Small for gestational age (SGA) refers to fetal growth less than the 10th percentile (RCOG, 2014), or if foetal growth is deemed unsatisfactory by the treating obstetrician.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified