ANZCTR - Registration

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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

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Metabolic and Endocrine

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]

Prevention

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Placebo - sugar pill, dosing schedule is the same as for the intervention.

Control group

Placebo

Outcomes

Primary outcome [1]

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]

26-28 weeks and 35-36 gestation

Secondary outcome [1]

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]

Any stage after randomisation

Secondary outcome [2]

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]

At birth

Secondary outcome [3]

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]

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]

5006

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Diabetes Society/Servier National Diabetes Strategy Grant

Address [1]

145 Macquarie Street
Sydney, NSW 2000

Tel: 61-2-9256 5462

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Merck Serono

Address [2]

Merck Sante S.A.S.
37 rue Saint-Romain
69008 Lyon

Country [2]

France

Funding source category [3]

Commercial sector/Industry

Name [3]

Novo Nordisk Australasia

Address [3]

P.O. Box 7586
Baulkham Hills Business Centre
NSW 2153

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CYWHS Human Research Ethics Committee

Ethics committee address [1]

72 King William Rd,
NORTH ADELAIDE  SA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/10/2008

Approval date [1]

18/12/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Suzette Coat

Address

University Department of Obstetrics and Gynaecology
72 King William Street,
NORTH ADELAIDE SA 5006

Country

Australia

Phone

+61 8 8313 1338

Fax

+61 8 8313 1333

suzette.coat@adelaide.edu.au

Contact person for scientific queries

Name

A/Prof W "Bill" Hague

Address

266 Melbourne Street,
NORTH ADELAIDE SA 5006

Country

Australia

Phone

+61 8 8361 7088

Fax

bill.hague@adelaide.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Email
23167	Study protocol	bill.hague@adelaide.edu.au
23168	Informed consent form	bill.hague@adelaide.edu.au
23169	Ethical approval	bill.hague@adelaide.edu.au

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.

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