Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000157077
Ethics application status
Approved
Date submitted
10/02/2010
Date registered
16/02/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Metformin in the Prevention of Gestational Diabetes: The MPG Trial
Scientific title
Metformin in the Prevention of recurrent Gestational Diabetes: A Double-blind Randomised Trial of Metformin versus placebo in pregnant women with previous gestational diabetes to prevent recurrent gestational diabetes.
Universal Trial Number (UTN)
U1111-1113-2319
Trial acronym
MPG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent gestational Diabetes 256436 0
Condition category
Condition code
Reproductive Health and Childbirth 256608 256608 0 0
Antenatal care
Metabolic and Endocrine 256609 256609 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomised to receive placebo or extended release (XR)metformin 500mg. From the time of randomisation (between 12 and 16 weeks gestation) the participant starts on one tablet orally per day. Dose is increased by one tablet per week up to 4 tablets daily (2000mg) or as tolerated. Participants continue on this dose until delivery.
Intervention code [1] 255735 0
Prevention
Intervention code [2] 255792 0
Treatment: Drugs
Comparator / control treatment
Placebo - sugar pill, dosing schedule is the same as for the intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 257506 0
Diagnosis of recurrent Gestational Diabetes - as determined either by Oral Glucose Tolerance Test or by high blood glucose levels on home blood glucose monitoring.
Timepoint [1] 257506 0
26-28 weeks and 35-36 gestation
Secondary outcome [1] 262725 0
Pregnancy hypertensive complication (with or without proteinuria) - as adjudged by the criteria of the Australian Society for the Study of Hypertension in Pregnancy (ASSHP).
Timepoint [1] 262725 0
Any stage after randomisation
Secondary outcome [2] 262815 0
Neonatal outcomes - composite of neonatal hypoglycaemia (heel prick testing of blood glucose levels in the neonate), respiratory distress (need for oxygen), need for phototherapy (diagnosis of hyperbilirubinaemia from a blood test), birth trauma, 5 minute apgar score<7, and prematurity.
Timepoint [2] 262815 0
At birth
Secondary outcome [3] 262816 0
Fetal macrosomia and neonatal adiposity. Fetal ultrasound will be used to assess growth of baby before birth. After birth the baby will be weighed on scales and skinfold thicknesses measured using skinfold callipers.
Timepoint [3] 262816 0
Measured at birth and at 6 weeks post partum (for neonatal adiposity).

Eligibility
Key inclusion criteria
Previous gestational diabetes,
Current viable, singleton pregnancy,
Gestational age=12 weeks 0 days to 15 weeks 6 days.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known Type 1, Type 2 or current gestational diabetes.
Abnormal renal or liver function, hypoxic cardio-repsiratory disease, malabsorption or significant gatro intestinal disorder, excessive alcohol intake, recreational drug use in pregnancy, known fetal anomaly, multiple gestation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible women are informed about the study. They are encouraged to discuss their participation with a family member, friend or health professional. After giving their consent potential subjects will undergo an Oral Glucose Tolerance Test (OGTT) to confirm that they do not already have recurrent gestational diabetes. Randomisation will be via telephone to central randomisation service. The subject will be randomised to intervention (metformin XR 500-2000mg) or placebo. Neither subject nor trial staff will know whether the subject is receiving placebo or metformin.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
266
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2383 0
5006

Funding & Sponsors
Funding source category [1] 256208 0
Charities/Societies/Foundations
Name [1] 256208 0
Australian Diabetes Society/Servier National Diabetes Strategy Grant
Country [1] 256208 0
Australia
Funding source category [2] 256209 0
Commercial sector/Industry
Name [2] 256209 0
Merck Serono
Country [2] 256209 0
France
Funding source category [3] 256285 0
Commercial sector/Industry
Name [3] 256285 0
Novo Nordisk Australasia
Country [3] 256285 0
Australia
Primary sponsor type
Hospital
Name
The Women's and Children's Hospital, a facility of the Children, Youth and Women’s Health Service Inc
Address
72 King William Rd,
NORTH ADELAIDE SA 5006
Country
Australia
Secondary sponsor category [1] 251605 0
None
Name [1] 251605 0
Address [1] 251605 0
Country [1] 251605 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258371 0
CYWHS Human Research Ethics Committee
Ethics committee address [1] 258371 0
72 King William Rd,
NORTH ADELAIDE SA 5006
Ethics committee country [1] 258371 0
Australia
Date submitted for ethics approval [1] 258371 0
20/10/2008
Approval date [1] 258371 0
18/12/2009
Ethics approval number [1] 258371 0
REC2117/11/11

Summary
Brief summary
The study wishes to explore whether using metformin from early in the second trimester of pregnancy can reduce the risk of recurrence of gestational diabetes.

The primary hypothesis is that "oral metformin, administered from early in the second trimester to women with a past history of gestational diabetes, will reduce the risk of recurrent gestational diabetes".

Pregnant women who have had gestational diabetes in a previous pregnancy will be invited to participate. They must be between 12 and 16 weeks gestation at the time of study enrolment. Once a woman has given her informed consent she will undergo an oral Glucose Tolerance Test (oGTT) and a fasting blood sample will be stored for measurement of insulin and other hormones. Any women with a positive oGTT will not be eligible for the study and will be given appropriate counselling and treatment for her recurrent gestational diabetes (rGDM). Those who have a normal oGTT result will be eligible to have medication randomly allocated. Baseline demographic and clinical data will be collected. Women will be randomised to medication. Neither the woman nor the study team will know whether the woman is receiving active treatment or placebo.

The woman will take her medication at the rate of one tablet per night for the next week. The dose will be increased by one tablet per week until a dose of four tablets a day is reached, or fewer as tolerated. Standard antenatal care will be received by all women on the study.

At 26-28 weeks gestation participants will be weighed, measured and have repeat oGTT and blood sample as above. Any women found to have rGDM will continue with her study medication and receive appropriate counselling and treatment of the rGDM.

At 35-36 weeks gestation the participants will again have a fasting blood sample taken, be weighed and measured.

Birth of the baby will be planned in conjunction with obstetric team, depending on obstetric and medical factors present at the time. Study medication may be stopped at onset of labour or 12hours prior to a booked caesarean section. A sample of the cord blood will be collected for measurement of glucose, insulin and other hormones. The baby will receive standard care as for the baby of a diabetic mother. The baby will have standard measures done, along with some extra ones for the study.

At 6 weeks after birth, the mother and baby will be measured again. The mother will undergo a repeat oGTT, as is standard for women with GDM, to determine if there is any ongoing diabetes or glucose intolerance. At this time a blood sample will again be taken for measurement of insulin and other hormones.
Trial website
None active
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 30640 0
Address 30640 0
Country 30640 0
Phone 30640 0
Fax 30640 0
Email 30640 0
Contact person for public queries
Name 13887 0
Suzette Coat
Address 13887 0
University Department of Obstetrics and Gynaecology
72 King William Street,
NORTH ADELAIDE SA 5006
Country 13887 0
Australia
Phone 13887 0
+61 8 8313 1338
Fax 13887 0
+61 8 8313 1333
Email 13887 0
[email protected]
Contact person for scientific queries
Name 4815 0
A/Prof W "Bill" Hague
Address 4815 0
266 Melbourne Street,
NORTH ADELAIDE SA 5006
Country 4815 0
Australia
Phone 4815 0
+61 8 8361 7088
Fax 4815 0
Email 4815 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23167Study protocol  [email protected]
23168Informed consent form  [email protected]
23169Ethical approval  [email protected]

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.