Randomised controlled trial of Gestational treatment with Ursodeoxycholic Acid compared to Metformin to Reduce effects of Diabetes mellitus - GUARD

King's College London0 sites158 target enrollmentJune 2, 2020

ConditionsGestational Diabetes Mellitus MedDRA version: 21.1Level: LLTClassification code 10018210Term: Gestational diabetes mellitusSystem Organ Class: 100000004868 Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

DrugsUrsofalk 500mg film-coated tablets Metformin 500mg Tablets BP

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Gestational Diabetes Mellitus
Sponsor: King's College London
Enrollment: 158
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 2, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

King's College London

Eligibility Criteria

Inclusion Criteria

•1\. Women between 16 and 45 years of age with GDM diagnosed at 26\+0 to 30\+6 weeks’ gestation in accordance with the NICE guidelines (one or more glucose concentrations of \=5\.6 mmol/l fasting or \=7\.8 mmol/l 2 hours after a standard 75g OGTT, and requiring pharmacological treatment).
•2\. Overweight or obese (Booking BMI \=25 kg/m2\)
•3\. Planned antenatal, birth intrapartum and postpartum care at the participating centre (i.e. not planning to move before delivery).
•Eligibility criteria for GUARD MEC is included in the protocol in section 19\.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 158
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 158
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range 0

Exclusion Criteria

•1\.Unwilling/unable to give written informed consent and comply with the requirements of the study protocol
•2\.Multiple pregnancies (twins, triplets etc) in current pregnancy
•3\.Congenital anomaly on ultrasound requiring fetal medicine input
•4\.Previous diagnosis of diabetes outside pregnancy
•5\.HbA1c at booking of current pregnancy of \>48 mmol/mol or \=6\.5% (if available)
•6\.Significant pre\-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in\-patient admission (within previous year) in the opinion of the responsible clinician or the CI.
•7\.Significant co\-morbidity in the current pregnancy, nephropathy (estimated GFR \<60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results in the opinion of the responsible clinician or the CI.
•8\.Not fluent in English and absence of interpreter or translation services (ie telephone translation services)
•9\.Participating in another intervention study where the results could influence GDM\-related endpoints, in the opinion of the responsible clinician or the CI, or participation in a CTIMP during current pregnancy.
•10\.Known allergy/hypersensitivity/intolerance to the active substance or excipients or patients taking any medications which are contraindicated as per IMP SmPC (as per Section 5\.7 of the protocol).