Gestational Diabetes Mellitus in PregnancyNCT06589141
Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes
A study testing MetFORMIN 500 Mg Oral Tablet and GlyBURIDE 2.5 MG Oral Tablet in people with Gestational Diabetes Mellitus in Pregnancy, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- MetFORMIN 500 Mg Oral Tablet and GlyBURIDE 2.5 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Jun 2026
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes: a Randomized Controlled Trial (GDM-MERGE Trial)
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.
Read the detailed description
Primary Outcome: treatment failure is defined as the initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects.
Secondary Outcomes:
Maternal:
- Percentage of fasting and postprandial glucose levels within target levels after initiation of treatment
- Incidence of maternal hypoglycemia
- Reported maternal side effects
- Maternal weight gain
- Preterm delivery
- Development of pregnancy-induced hypertension
- Labor dystocia.
- Instrumental delivery and its indication (fetal compromise, delay in progress, or maternal exhaustion)
- Mode of delivery
- Incidence of third and fourth perineal tear
Fetal and neonatal:
- Fetal large for gestational age
- Intrauterine fetal death
- Newborn weight
- Gestational age at delivery
- Neonatal birth injuries
- Stillbirth and neonatal death
- Apgar score at 1 minute
- Being tested
- MetFORMIN 500 Mg Oral Tablet, GlyBURIDE 2.5 MG Oral Tablet
- Keywords
- Metformin and Glyburide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetFORMIN 500 Mg Oral TabletDrug
Metformin (500 to 2000 mg orally)
GlyBURIDE 2.5 MG Oral TabletDrug
Glyburide (2.5 mg to 20 mg orally)
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin (500 to 2000 mg orally) Receives: Drug: MetFORMIN 500 Mg Oral Tablet |
| Glyburide | Experimental | Glyburide (2.5 mg to 20 mg orally) Receives: Drug: GlyBURIDE 2.5 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From 28 weeks till 41 weeks of pregnancy
Secondary outcomes (3)
Incidence of maternal hypoglycemia
Incidence of blood glucose levels below 4 mmol/L during the period of treatment
Measured: From 28 weeks till 41 weeks of pregnancy
Significant side effects
Incidence of maternal significant side effects requiring cessation of treatment (gastrointestinal side effects)
Measured: From 28 weeks till 41 weeks of pregnancy
Fetal macrosomia (large for gestational age)
Incidence of fetuses growing above the 90th percentile on third ultrasound scan using customised growth chart
Measured: 32 weeks of gestation to onset of labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Middle-Eastern College of Obstetricians and Gynecologists
- Responsible party
- Principal investigator, Sherif Abdelkarim Mohammed Shazly, Middle-Eastern College of Obstetricians and Gynecologists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589141
- Sponsor's protocol ID
- GDM-MERGE trial
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35613728Silva 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.
PubMed 22505499Shuster 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.
PubMed 31869430Oliveira 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.
PubMed 35195193
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes: a Randomized Controlled Trial (GDM-MERGE Trial)
- ClinicalTrials.gov ID
- NCT06589141
- Acronym / sponsor ID
- GDM-MERGE trial
- Keywords
- Metformin and Glyburide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Middle-Eastern College of Obstetricians and Gynecologists
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
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.
Detailed description
Primary Outcome: treatment failure is defined as the initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects.
Secondary Outcomes:
Maternal:
- Percentage of fasting and postprandial glucose levels within target levels after initiation of treatment
- Incidence of maternal hypoglycemia
- Reported maternal side effects
- Maternal weight gain
- Preterm delivery
- Development of pregnancy-induced hypertension
- Labor dystocia.
- Instrumental delivery and its indication (fetal compromise, delay in progress, or maternal exhaustion)
- Mode of delivery
- Incidence of third and fourth perineal tear
Fetal and neonatal:
- Fetal large for gestational age
- Intrauterine fetal death
- Newborn weight
- Gestational age at delivery
- Neonatal birth injuries
- Stillbirth and neonatal death
- Apgar score at 1 minute
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetFORMIN 500 Mg Oral TabletMetformin (500 to 2000 mg orally) |
| Glyburide | Experimental | Drug: GlyBURIDE 2.5 MG Oral TabletGlyburide (2.5 mg to 20 mg orally) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
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 500 Mg Oral TabletMetformin (500 to 2000 mg orally) | Drug | Metformin |
| GlyBURIDE 2.5 MG Oral TabletGlyburide (2.5 mg to 20 mg orally) | Drug | Glyburide |
Primary outcome
Treatment failure
Time frame: From 28 weeks till 41 weeks of pregnancy
Initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects
3 secondary outcomes
Incidence of maternal hypoglycemia
Time frame: From 28 weeks till 41 weeks of pregnancy
Significant side effects
Time frame: From 28 weeks till 41 weeks of pregnancy
Fetal macrosomia (large for gestational age)
Time frame: 32 weeks of gestation to onset of labour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 35613728Ye 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.
- Background: PubMed 22505499Silva 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.
- Background: PubMed 31869430Shuster 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.
- Background: PubMed 35195193Oliveira 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.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing MetFORMIN 500 Mg Oral Tablet and GlyBURIDE 2.5 MG Oral Tablet in people with Gestational Diabetes Mellitus in Pregnancy, run by Assiut University.
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 4 inclusion and 10 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Sherif Shazly, MSc (+447554480388, shazly.sherif2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: From 28 weeks till 41 weeks of pregnancy). 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 NCT06589141, which also lists 4 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 19 Sep 2024.