NCT06589141

Brief Summary

This study aims to compare the maternal, fetal, and neonatal outcomes associated with the use of metformin versus glyburide for managing gestational diabetes. The objective is to assess the safety and effectiveness profiles of both medications as potential alternatives to initiating insulin therapy.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jan 2025

Status
not yet recruiting

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 Progress90%
Jan 2025Jun 2026

First Submitted

Initial submission to the registry

August 26, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

August 26, 2024

Last Update Submit

September 5, 2024

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

Metformin and Glyburide

Outcome Measures

Primary Outcomes (1)

  • Treatment failure

    Initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects

    From 28 weeks till 41 weeks of pregnancy

Secondary Outcomes (3)

  • Incidence of maternal hypoglycemia

    From 28 weeks till 41 weeks of pregnancy

  • Significant side effects

    From 28 weeks till 41 weeks of pregnancy

  • Fetal macrosomia (large for gestational age)

    32 weeks of gestation to onset of labour

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin (500 to 2000 mg orally)

Drug: MetFORMIN 500 Mg Oral Tablet

Glyburide

EXPERIMENTAL

Glyburide (2.5 mg to 20 mg orally)

Drug: GlyBURIDE 2.5 MG Oral Tablet

Interventions

MetFORMIN 500 Mg Oral TabletDRUG

Metformin (500 to 2000 mg orally)

Metformin
GlyBURIDE 2.5 MG Oral TabletDRUG

Glyburide (2.5 mg to 20 mg orally)

Glyburide

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women over 18 years old.
  • Gestational age between 24 - 28 weeks.
  • New diagnosis of gestational diabetes mellitus using a 2-hour glucose tolerance test.
  • Medical therapy is indicated to control blood glucose following the failure of diet and lifestyle changes to solely achieve glycemic control (A2GDM).

You may not qualify if:

  • Patients with pre-gestational diabetes.
  • First trimester fasting blood glucose ≥105 mg/dl or HbA1c \> 6.4%.
  • Major fetal anomalies.
  • Intrauterine growth restriction (IUGR) before 24 weeks.
  • Abnormal renal or liver function.
  • Contraindications to metformin or glyburide.
  • Medical treatment declined by the patient.
  • Direct indication to commence insulin (initial fasting blood glucose \>= 7 mmol/l or 126 mg/dl or \>= 6 mmol/l or 108 mg/dl with macrosomia or polyhydramnios).
  • Significant medical co-morbidities requiring continuous medical treatment in pregnancy.
  • Non-compliance to blood glucose self-monitoring (missing 50% or more of total readings)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Ye W, Luo C, Huang J, Li C, Liu Z, Liu F. Gestational diabetes mellitus and adverse pregnancy outcomes: systematic review and meta-analysis. BMJ. 2022 May 25;377:e067946. doi: 10.1136/bmj-2021-067946.

    PMID: 35613728BACKGROUND

  • Silva JC, Fachin DR, Coral ML, Bertini AM. Perinatal impact of the use of metformin and glyburide for the treatment of gestational diabetes mellitus. J Perinat Med. 2012 Jan 10;40(3):225-8. doi: 10.1515/jpm-2011-0175.

    PMID: 22505499BACKGROUND

  • Shuster DL, Shireman LM, Ma X, Shen DD, Flood Nichols SK, Ahmed MS, Clark S, Caritis S, Venkataramanan R, Haas DM, Quinney SK, Haneline LS, Tita AT, Manuck TA, Thummel KE, Brown LM, Ren Z, Brown Z, Easterling TR, Hebert MF. Pharmacodynamics of Glyburide, Metformin, and Glyburide/Metformin Combination Therapy in the Treatment of Gestational Diabetes Mellitus. Clin Pharmacol Ther. 2020 Jun;107(6):1362-1372. doi: 10.1002/cpt.1749. Epub 2020 Jan 25.

    PMID: 31869430BACKGROUND

  • Oliveira MM, Andrade KFO, Lima GHS, Rocha TC. Metformin versus glyburide in treatment and control of gestational diabetes mellitus: a systematic review with meta-analysis. Einstein (Sao Paulo). 2022 Feb 16;20:eRW6155. doi: 10.31744/einstein_journal/2022RW6155. eCollection 2022.

    PMID: 35195193BACKGROUND

MeSH Terms

Interventions

MetforminTabletsGlyburide

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsDosage FormsPharmaceutical PreparationsSulfonylurea CompoundsUreaAmidesSulfonesSulfur Compounds

Central Study Contacts

Sherif Shazly, MSc

CONTACT

+447554480388shazly.sherif2020@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior clinical fellow

Study Record Dates

First Submitted

August 26, 2024

First Posted

September 19, 2024

Study Start

January 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share