Gestational Diabetes MellitusPhase 4PRoDroMENCT02394158
Preventing Recurrent Gestational Diabetes With Metformin
A Phase 4 study testing Metformin in people with Gestational Diabetes Mellitus, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent gestational diabetes mellitus recurring in previously affected pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 27 Jan 2015to 30 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy;
- 8-22 weeks gestation
- Previous pregnancy complicated by gestational diabetes
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Imperial College NHS Trust
London, W2 1PG
Stephen Robinson, FRCP, MD, 0203 312 1253
Rochan Agha-Jaffar, BMBS, MRCP, 0207 594 6140, r.agha-jaffar@imperial.ac.uk
- Recruiting
London North West Healthcare Trust
London
Mushtaqur Rahman, FRCP, PhD
Rochan Agha-Jaffar, BMBS, MRCP, 0207 594 6140, r.agha-jaffar@imperial.ac.uk
About this study
Official title: Preventing Recurrent Gestational Diabetes Mellitus With Early Metformin Intervention
Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent gestational diabetes mellitus recurring in previously affected pregnancies.
Read the 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
- Being tested
- Metformin, placebo
- Keywords
- Recurrent Gestational Diabetes Mellitus, Prevention, Metformin
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Gestational Diabetes at any point during the course of pregnancy
Measured: From 12 weeks pregnancy until the onset of labour
Secondary outcomes (7)
Maternal gestational weight gain
Measured: Difference between weight at 12 weeks gestation and 36 weeks gestation
Requirement for insulin therapy
Measured: From 12 weeks gestation until 36 weeks gestation
Postpartum glucose levels
Measured: 6 weeks postpartum
Levels of maternal physical and psychological health as assessed by questionnaires
Measured: From 12 weeks gestation until 6 weeks postpartum
Fetal birthweight and birthweight centile
Measured: At Birth
Composite of neonatal outcomes (neonatal hypoglycaemia requiring treatment, respiratory distress syndrome requiring oxygen therapy/ continuous positive airway pressure, neonatal hyperbilirubinaemia requiring phototherapy).
Measured: At Birth
Cost effectiveness of the intervention
Difference in requirement for medical services and unplanned hospital/ General Practitioner attendances between the two arms
Measured: From 12 weeks gestation until 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start27 Jan 2015
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, London North West Healthcare NHS Trust, Novo Nordisk Foundation
- Responsible party
- Sponsor
- Investigators
- Stephen Robinson, FRCP, MD, Principal investigator, Imperial College NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394158
- Sponsor's protocol ID
- 14SM1971
- Other IDs
- 2014-001244-38, 2014
- Acronym
- PRoDroME
- Status last verified
- Aug 2019
- First submitted
- 2 Mar 2015
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18463375Rowan 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.
PubMed 18463376Getahun 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.
PubMed 20630491Thangaratinam 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.
PubMed 22596383De 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.
PubMed 21530058
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Recurrent Gestational Diabetes Mellitus With Early Metformin Intervention
- ClinicalTrials.gov ID
- NCT02394158
- Acronym / sponsor ID
- PRoDroME / 14SM1971
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Recurrent Gestational Diabetes Mellitus, Prevention, Metformin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, London North West Healthcare NHS Trust, Novo Nordisk Foundation
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm Metformin | Active comparator | Drug: MetforminMetformin (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. |
| Control arm placebo | Placebo comparator | Drug: placeboMatched 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy;
- 8-22 weeks gestation
- Previous pregnancy complicated by gestational diabetes
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin | Drug | Intervention arm Metformin |
| placebo | Drug | Control arm placebo |
Primary outcome
Development of Gestational Diabetes at any point during the course of pregnancy
Time frame: From 12 weeks pregnancy until the onset of labour
7 secondary outcomes
Maternal gestational weight gain
Time frame: Difference between weight at 12 weeks gestation and 36 weeks gestation
Requirement for insulin therapy
Time frame: From 12 weeks gestation until 36 weeks gestation
Postpartum glucose levels
Time frame: 6 weeks postpartum
Levels of maternal physical and psychological health as assessed by questionnaires
Time frame: From 12 weeks gestation until 6 weeks postpartum
Fetal birthweight and birthweight centile
Time frame: At Birth
Composite of neonatal outcomes (neonatal hypoglycaemia requiring treatment, respiratory distress syndrome requiring oxygen therapy/ continuous positive airway pressure, neonatal hyperbilirubinaemia requiring phototherapy).
Time frame: At Birth
Cost effectiveness of the intervention
Time frame: From 12 weeks gestation until 6 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Background: PubMed 18463375HAPO 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.
- Background: PubMed 18463376Rowan 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.
- Background: PubMed 20630491Getahun 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.
- Background: PubMed 22596383Thangaratinam 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.
- Background: PubMed 21530058De 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.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes Mellitus
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
RecruitingEarly Phase 1
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
Gestational Diabetes
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Robinson, FRCP, MD principal investigator
Imperial College NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Gestational Diabetes Mellitus, run by Imperial College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Robinson, FRCP, MD (0203 312 1253, stephen.robinson@imperial.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Gestational Diabetes at any point during the course of pregnancy (time frame: From 12 weeks pregnancy until the onset of labour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02394158, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.