Gestational Diabetes Mellitus MedDRA version: 21.1 Level: LLT Classification code 10018210 Term: Gestational diabetes mellitus System Organ Class: 100000004868
Conditions
Interventions
Trade Name: Glucophage
Product Name: Glucophage 500mg IR tablets
Pharmaceutical Form: Coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(
Sponsors
National University of ireland Galway
Eligibility
Sex/Gender
All
Inclusion criteria
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 /=10mmol/l, or c. 2 hour post glucose load of >/=8.5 mmol/l and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine if metformin (a) reduces the requirement for insulin or (b) reduces fasting glucose at gestational weeks 32 and 38.;Secondary Objective: Additional secondary objectives of this study are to determine if metformin; delays the initiation of insulin; reduces the insulin dose required; impacts on maternal body weight, BMI, waist circumference, blood glucose status, insulin resistance status and metabolic syndrome postpartum; reduces the proportion of infants with morbidities; in addition to standard care reduces infant birth weight when compared to standard care alone; reduces the proportion of maternal morbidities when compared to standard care alone; in addition to standard care reduces excessive maternal gestational weight gain; to determine if women consider metformin a more acceptable treatment than insulin; to determine the cost, cost effectiveness, and budget impact of metformin in addition to standard care for gestational diabetes mellitus. ;Primary end point(s): The primary efficacy outcome is a composite of: • Insulin initiation (Yes/No) • Fasting glucose value 5.1 mmol/l ;Timepoint(s) of evaluation of this end point: Insulin initiation will be measured at all time points throughout the trial Fasting glucose will be evaluated at gestational weeks 32 and 38. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy outcomes include: 1. Time to insulin initiation and insulin dose required 2. Maternal morbidity at delivery (hypertensive disorders, antepartum and postpartum haemorrhage, polyhydramnios) 3. Mode and time of delivery 4. Postpartum glucose status, insulin resistance, and metabolic syndrome 5. Postpartum BMI, gestational weight gain, and waist circumference 6. Infant birth weight 7. Neonatal height and head circumference at delivery 8. Neonatal morbidities (Need for neonatal care unit, respiratory distress, jaundice, congenital anomalies, Apgar score) 9. Neonatal hypoglycaemia (defined as plasma glucose <2.6 mmoL/L on one or more occasions starting 30-60 minutes after birth). 10. Cost effectiveness and budget impact of metformin treatment in addition to standard care 11. Treatment acceptability (DTSQ and Rowan questionnaires) 12. Quality of Life determined by EQ5D-5L questionnaire ;Timepoint(s) of evaluation of this end point: Time to insulin initiation and insulin dose required will be measured at all time points throughout the trial. Maternal morbidity, mode and time of delivery, infant birth weight, neonatal morbidities and hypoglycaemia, and neonatal height and head circumference will be measured at delivery. Postpartum BMI, gestational weight gain, waist circumference, glucose status, insulin resistance, and metabolic syndrome will be measured at 12-16 weeks post-partum. Cost effectiveness of metformin treatment in addition to standard care will be measured at 12 weeks post-partum. Treatment acceptability will be measured at week 12 post randomisation and at 4 weeks post-partum. Quality of Life determined by EQ5D-5L questionnaire measured at baseline, 4 weeks post-partum, and 12 weeks post-partum. | — |
Countries
Ireland
Contacts
Public ContactMarie Browne
HRB Clinical Research Facility Galway
Outcome results
None listed