NCT02394158

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

4.7 years

First QC Date

March 2, 2015

Last Update Submit

August 12, 2019

Conditions

Gestational Diabetes Mellitus

Keywords

Recurrent Gestational Diabetes MellitusPreventionMetformin

Outcome Measures

Primary Outcomes (1)

  • Development of Gestational Diabetes at any point during the course of pregnancy

    From 12 weeks pregnancy until the onset of labour

Secondary Outcomes (7)

  • Maternal gestational weight gain

    Difference between weight at 12 weeks gestation and 36 weeks gestation

  • Requirement for insulin therapy

    From 12 weeks gestation until 36 weeks gestation

  • Postpartum glucose levels

    6 weeks postpartum

  • Levels of maternal physical and psychological health as assessed by questionnaires

    From 12 weeks gestation until 6 weeks postpartum

  • Fetal birthweight and birthweight centile

    At Birth

  • +2 more secondary outcomes

Other Outcomes (3)

  • Insulin resistance

    From 12 weeks gestation until 6 weeks postpartum

  • Maternal triglyceride concentrations

    From 12 weeks gestation until 6 weeks postpartum

  • Fetal hyperinsulinaemia

    Delivery

Study Arms (2)

Intervention arm Metformin

ACTIVE COMPARATOR

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.

Drug: Metformin

Control arm placebo

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

MetforminDRUG
Intervention arm Metformin
placeboDRUG
Control arm placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSingleton pregnancy; in 8-22 weeks gestation, previous pregnancy complicated by gestational diabetes
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy;
  • weeks gestation
  • Previous pregnancy complicated by gestational diabetes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imperial College NHS Trust

London, W2 1PG, United Kingdom

RECRUITING

London North West Healthcare Trust

London, United Kingdom

RECRUITING

Related Publications (5)

  • 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.

    PMID: 18463375BACKGROUND

  • 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.

    PMID: 18463376BACKGROUND

  • 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.

    PMID: 20630491BACKGROUND

  • 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.

    PMID: 22596383BACKGROUND

  • 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.

    PMID: 21530058BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Metformin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Stephen Robinson, FRCP, MD

    Imperial College NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Robinson, FRCP, MD

CONTACT

0203 312 1253stephen.robinson@imperial.nhs.uk

Rochan Agha-Jaffar, BMBS, MRCP

CONTACT

0207 594 6140r.agha-jaffar@imperial.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 20, 2015

Study Start

January 27, 2015

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)