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Trial record 9 of 103 for:    Recruiting, Not yet recruiting, Available Studies | "Diabetes, Gestational"

A Clinical Trial of the Effectiveness of Metformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus (EMERGE)

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ClinicalTrials.gov Identifier: NCT02980276
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : September 12, 2017
Sponsor:
Collaborators:
Health Research Board, Ireland
HRB Clinical Research Facility Galway, Ireland
Cork University Hospital
University College Hospital Galway
Information provided by (Responsible Party):
Fidelma Dunne, National University of Ireland, Galway, Ireland

Brief Summary:
The overall objective of the EMERGE trial is to determine whether metformin + usual care, compared to placebo + usual care (introduced at the time of initial diagnosis of GDM), reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for women with Gestational Diabetes Mellitus.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Drug: Metformin Hydrochloride Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Placebo Controlled Trial of the Effectiveness of Early MEtformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE)
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment
Participants randomised to the treatment arm will receive active metformin in addition to standard care. Metformin tablets will be titrated according to a dosing schedule to achieve the pre-specified glucose targets. Tablets will be in 500mg doses and will commence at 1 tablet per day (500mg) increasing to a maximum of 5 tablets per day (2500mg).
Drug: Metformin Hydrochloride
Women randomised to the metformin group will receive metformin 500mg OD, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of 2500mg Metformin daily (5 tablets) or maximum tolerated dose, in addition to usual care (exercise and MNT), and taken until delivery.

Placebo Comparator: Control
Participants randomised to the placebo arm will receive placebo in addition to standard care. Placebo will be titrated according to the dosing schedule to achieve the pre-specified glucose targets. Placebo tablets will commence at 1 tablet per day and will be increased to a maximum of 5 tablets per day over 10 days as with the treatment group.
Other: Placebo
Women randomised to the placebo group will receive 1 placebo tablet OD, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of five placebo tablets daily, in addition to usual care (exercise and MNT), and taken until delivery.




Primary Outcome Measures :
  1. Insulin Initiation/Fasting Glucose [ Time Frame: Change from Gestational Weeks 32 and 38 ]

    The primary efficacy outcome is a composite of:

    • Insulin initiation (Yes/No)
    • Fasting glucose value </=5.1 mmol/l and >5.1 mmol/l


Secondary Outcome Measures :
  1. Time to Insulin Initiation [ Time Frame: Time to Insulin Initiation, from date of randomization until the date delivery, assessed up to 40 weeks ]
    Time to Insulin Initiation, from date of randomization until the date delivery, assessed up to 40 weeks

  2. Maternal Morbidity at Delivery [ Time Frame: Delivery ]
    Number of women with maternal morbidity at delivery that is related to treatment (e.g. hypertensive disorders, antepartum/postpartum haemorrhage, polyhydroaminos)

  3. Mode of Delivery [ Time Frame: Delivery ]
    Mode of delivery (e.g. vaginal, cesarean)

  4. Time of Delivery [ Time Frame: Delivery ]
    Gestational weeks at delivery

  5. Postpartum glucose status, insulin resistance, and metabolic syndrome [ Time Frame: 12 weeks post-partum ]
    Number of women with abnormal glucose values/insulin resistance/metabolic syndrome

  6. Post-partum BMI [ Time Frame: 12 weeks post-partum ]
    Post-partum BMI in kg/m2 in participants between groups

  7. Infant Birth Weight [ Time Frame: Delivery ]
    Weight in kg at birth

  8. Neonatal height and head circumference at delivery [ Time Frame: Delivery ]
    Height in cm Head circumference in cm

  9. Neonatal morbidities [ Time Frame: Delivery ]
    Number of neonates with respiratory distress, jaundice, congenital anomalies, need for neonatal care unit

  10. Neonatal hypoglyceamia [ Time Frame: Delivery ]
    Number of neonates with glucose <2.6mmol/l

  11. Neonatal hypoglyceamia [ Time Frame: 12 weeks post-partum ]
    Number of neonates with glucose <2.6mmol/l

  12. Treatment Acceptibility [ Time Frame: 4 weeks post-partum ]
    Treatment acceptability determined by Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Rowan Questionnaire

  13. Quality of Life [ Time Frame: Treatment week 12 ]
    Quality of Life determined by EQ5D-5L Questionnaire

  14. Post partum waist circumference [ Time Frame: 12 weeks post partum ]
    waist circumference in cm in participants between groups

  15. Gestational weight gain [ Time Frame: Change in weight from 24 weeks gestation until last visit before delivery ]
    Change in weight (kg) from 24 weeks gestation until last visit before delivery


Other Outcome Measures:
  1. Cost effectiveness and budget impact of metformin treatment in addition to standard care [ Time Frame: 24 weeks gestation to 12 weeks post-partum ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide written informed consent
  2. Women aged 18-50
  3. Pregnancy gestation between 24 and 28 weeks
  4. Singleton pregnancy as determined by scan
  5. Positive diagnosis of Gestational Diabetes Mellitus on a OGTT according to IADPSG criteria if any one of the following are achieved: i) Fasting glucose >/= 5.1mmol/l and <7mmol/l, or ii) 1 hour post glucose load of >/=10mmol/l, or iii) 2 hour post glucose load of >/=8.5 mmol/l and <11.1mmo/l
  6. Resident in the locality and intending to deliver within the trial site

Exclusion Criteria:

  1. Women who have an established diagnosis of diabetes (Type 1, Type 2, Monogenic or secondary)
  2. Women with a fasting glucose > 7mmol/l or a 2h value > 11.1 mmol/l
  3. Multiple pregnancies (twins, triplets etc.) as determined by scan
  4. Known intolerance to metformin
  5. Known contraindication to the use of metformin which include: i) renal insufficiency (defined as serum creatinine of greater than 130 µmol/L or creatinine clearance <60 ml/min), ii) moderate to severe liver dysfunction (alkaline phosphatase and alanine aminotransferase greater than 3 times the upper limit of normal, iii) shock or sepsis, and iv) previous hypersensitivity to metformin
  6. Known fetal anomaly as determined by early or mid-trimester scan
  7. Known small for gestational age1 determined by early or mid-trimester scan
  8. Known gestational hypertension or pre-eclampsia or ruptured membranes
  9. Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
  10. Women with significant gastrointestinal problems such as severe vomiting, Crohn's disease or colitis which will inadvertently affect absorption of the study drug
  11. Women with congestive heart failure or history of congestive heart failure
  12. Women with serious mental illness which would affect adherence to study medication or compliance with study protocol in the opinion of the investigator
  13. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980276


Contacts
Contact: Prof. Fidelma Dunne 003539149 ext 5074 fidelma.dunne@nuigalway.ie

Locations
Ireland
Cork University Hospital Not yet recruiting
Cork, Ireland
Principal Investigator: Prof. Louise Kenny         
University Hospital Galway Recruiting
Galway, Ireland
Principal Investigator: Prof. Fidelma Dunne         
Sponsors and Collaborators
National University of Ireland, Galway, Ireland
Health Research Board, Ireland
HRB Clinical Research Facility Galway, Ireland
Cork University Hospital
University College Hospital Galway

Responsible Party: Fidelma Dunne, Prof. Fidelma Dunne, National University of Ireland, Galway, Ireland
ClinicalTrials.gov Identifier: NCT02980276     History of Changes
Other Study ID Numbers: NUIG-2016-01
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fidelma Dunne, National University of Ireland, Galway, Ireland:
Gestational Diabetes
Diabetes
Pregnancy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs