Preventing Recurrent Gestational Diabetes With Metformin

NCT ID: NCT02394158

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-27
• Study Completion Date: 2019-09-30

Brief Summary

Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent gestational diabetes mellitus recurring in previously affected pregnancies.

Detailed Description

Gestational diabetes mellitus (GDM) is a common medical complication of pregnancy and is associated with increased risks to mother and baby. The incidence is increasing reflecting changing pre-gravid female demographics. Once one pregnancy is complicated by GDM, subsequent pregnancies are more likely to be affected by the same condition. This reported risk of recurrence is estimated to range between 35 and 80%, with non-caucasian ethnicity being the strongest predictor of GDM recurrence. Evidence regarding further predictors of recurrent GDM is conflicting and measures that might prevent recurrence need exploring.

Metformin is commonly used in the treatment of established GDM and has been shown to reduce the incidence of GDM in the context of polycystic ovarian syndrome.

Conditions

Gestational Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Intervention arm Metformin

Metformin (500mg tablets) to start at a dose of 500mg once daily with an increase of 500mg every five days until the maximum dose of 1000mg twice daily is reached.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Control arm placebo

Matched placebo tablets (500mg) to start at a dose of 500mg once daily with an increase of 500mg every five days until the maximum dose of 1000mg twice daily is reached.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Metformin

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Singleton pregnancy;
• 8-22 weeks gestation
• Previous pregnancy complicated by gestational diabetes

Exclusion Criteria

• Established pre-existing diabetes (including unrecognised diabetes defined as a fasting plasma glucose ≥ 7.0mmol/L and/ or HbA1c ≥ 48mmol/mol); Contraindications to metformin therapy (creatinine ≥ 130μmol/L/ alanine transaminase ≥ 2.0 x upper limit normal/ previous intolerance to metformin)
• Planned continued antenatal care/ delivery at centre not included in trial
• Planned fast for cultural/ religious reasons e.g. Ramadan

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

London North West Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

The Novo Nordisk UK Research Foundation

UNKNOWN

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Robinson, FRCP, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College NHS Trust

Locations

Imperial College NHS Trust

London, , United Kingdom

Site Status: RECRUITING

London North West Healthcare Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Stephen Robinson, FRCP, MD

Role: CONTACT

stephen.robinson@imperial.nhs.uk

0203 312 1253

Rochan Agha-Jaffar, BMBS, MRCP

Role: CONTACT

r.agha-jaffar@imperial.ac.uk

0207 594 6140

Facility Contacts

Stephen Robinson, FRCP, MD

Role: primary

0203 312 1253

Rochan Agha-Jaffar, BMBS, MRCP

Role: backup

r.agha-jaffar@imperial.ac.uk

0207 594 6140

Mushtaqur Rahman, FRCP, PhD

Role: primary

Rochan Agha-Jaffar, BMBS, MRCP

Role: backup

r.agha-jaffar@imperial.ac.uk

0207 594 6140

References

HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.

Reference Type: BACKGROUND

PMID: 18463375 (View on PubMed)

Rowan JA, Hague WM, Gao W, Battin MR, Moore MP; MiG Trial Investigators. Metformin versus insulin for the treatment of gestational diabetes. N Engl J Med. 2008 May 8;358(19):2003-15. doi: 10.1056/NEJMoa0707193.

Reference Type: BACKGROUND

PMID: 18463376 (View on PubMed)

Getahun D, Fassett MJ, Jacobsen SJ. Gestational diabetes: risk of recurrence in subsequent pregnancies. Am J Obstet Gynecol. 2010 Nov;203(5):467.e1-6. doi: 10.1016/j.ajog.2010.05.032. Epub 2010 Jul 13.

Reference Type: BACKGROUND

PMID: 20630491 (View on PubMed)

Thangaratinam S, Rogozinska E, Jolly K, Glinkowski S, Roseboom T, Tomlinson JW, Kunz R, Mol BW, Coomarasamy A, Khan KS. Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence. BMJ. 2012 May 16;344:e2088. doi: 10.1136/bmj.e2088.

Reference Type: BACKGROUND

PMID: 22596383 (View on PubMed)

De Leo V, Musacchio MC, Piomboni P, Di Sabatino A, Morgante G. The administration of metformin during pregnancy reduces polycystic ovary syndrome related gestational complications. Eur J Obstet Gynecol Reprod Biol. 2011 Jul;157(1):63-6. doi: 10.1016/j.ejogrb.2011.03.024. Epub 2011 May 6.

Reference Type: BACKGROUND

PMID: 21530058 (View on PubMed)

Other Identifiers

2014-001244-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14SM1971

Identifier Type: -

Identifier Source: org_study_id