Gestational DiabetesPhase 4NCT06781775
GDM: Insulin with or Without Metformin?
A Phase 4 study testing Metformin + Insulin and Insulin in people with Gestational Diabetes, run by University of Virginia at 1 site in United States.
Trial summary
This will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin. It will examine whether continuing metformin when adding insulin versus discontinuing metformin when insulin is added is beneficial. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Metformin + Insulin and Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 1 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment
- Ability to take oral medication and be willing to adhere to the metformin regimen
- Willing to take insulin if needed
- Willing to take blood sugars 4 times per day
- -
Who cannot join
- 1) Metformin allergy or known intolerance, known hypersensitivity to insulin 2) Severe hepatic dysfunction 3) Chronic kidney disease 4) Pregnancy with major fetal anomalies 5) Non-viable pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Amanda Urban, 4344093100, ajr5y@uvahealth.org
Christopher Ennen, MD
About this study
Official title: Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial
This will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin. It will examine whether continuing metformin when adding insulin versus discontinuing metformin when insulin is added is beneficial. The investigators hypothesize that continuing metformin will reduce the needed insulin dosage and improve maternal and neonatal outcomes in these patients.
Read the detailed description
This research study is being conducted to better treat patients who develop gestational diabetes which is diabetes that is diagnosed and present only during the course of pregnancy. Normally patients that develop gestational diabetes are treated with either metformin or insulin. Some need treatment with both. Both are considered safe in pregnancy and both are considered as standard treatments by national guidelines. Many patients ask to start with metformin because it is easy to take and does not require an injection. Sometimes, patients' blood sugars are not controlled enough on metformin so they need insulin to assist with control of the blood sugars. The investigators are studying patients who have tried metformin for gestational diabetes but did not have enough blood sugar control on metformin alone so they require insulin. The investigators are specifically looking at whether metformin should be continued when insulin is added or if metformin should be stopped. This has not been studied and nobody knows the correct answer on whether people should keep taking metformin when they need insulin or if they should stop the metformin. Some physicians decide to continue metformin with insulin and some do not since the investigators do not have an answer based on available research.
Patients will be split into two groups that are random. One group will continue metformin in addition to insulin and another group will stop taking metformin when insulin is needed to control their gestational diabetes. Some people may not want to take a pill and a shot and some may want to take a pill if it means taking less medication through shots.
This research questions is important because it will tell us how to better treat gestational diabetes and whether continuing metformin allows us to use less insulin. This could possibly mean less cost for the patient, a better medication schedule (less dose and/or less shots), better blood sugar control, better health benefits for the patient, and/or better health benefits for the baby.
This study is very similar to how current medical practice in obstetrics is currently as some providers continue metformin when insulin is needed and some discontinue it.
This research has not been done in patients with gestational diabetes before in this way. Metformin and insulin have been researched in pregnancy and are both considered standard treatments for gestational diabetes but they have not been researched like this together.
- Conditions
- Gestational Diabetes
- Being tested
- Metformin + Insulin, Insulin
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin + InsulinDrug
Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stay on metformin and add insulin.
InsulinDrug
Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stop on metformin and add insulin.
| Study group | Role | What they receive |
|---|---|---|
| Metformin + Insulin | Active comparator | Pregnant women with gestational diabetes who have uncontrolled blood sugar on metformin alone will be started on insulin and will stay on metformin. Receives: Drug: Metformin + Insulin |
| Insulin | Active comparator | Pregnant women with gestational diabetes who have uncontrolled blood sugar on metformin along will be started on insulin and metformin will be discontinued. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if metformin reduces amount of insulin in patients with gestational diabetes who already require insulin
Insulin dosage (units per kilogram body weight) at last visit prenatal visit
Measured: From enrollment into study until delivery, maximum 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start12 Dec 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher S. Ennen, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781775
- Sponsor's protocol ID
- 231576
- Status last verified
- Dec 2024
- First submitted
- 18 Mar 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06781775
- Acronym / sponsor ID
- 231576
- Conditions
- Gestational Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 17 Jan 2025 (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 will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin. It will examine whether continuing metformin when adding insulin versus discontinuing metformin when insulin is added is beneficial. The investigators hypothesize that continuing metformin will reduce the needed insulin dosage and improve maternal and neonatal outcomes in these patients.
Detailed description
This research study is being conducted to better treat patients who develop gestational diabetes which is diabetes that is diagnosed and present only during the course of pregnancy. Normally patients that develop gestational diabetes are treated with either metformin or insulin. Some need treatment with both. Both are considered safe in pregnancy and both are considered as standard treatments by national guidelines. Many patients ask to start with metformin because it is easy to take and does not require an injection. Sometimes, patients' blood sugars are not controlled enough on metformin so they need insulin to assist with control of the blood sugars. The investigators are studying patients who have tried metformin for gestational diabetes but did not have enough blood sugar control on metformin alone so they require insulin. The investigators are specifically looking at whether metformin should be continued when insulin is added or if metformin should be stopped. This has not been studied and nobody knows the correct answer on whether people should keep taking metformin when they need insulin or if they should stop the metformin. Some physicians decide to continue metformin with insulin and some do not since the investigators do not have an answer based on available research.
Patients will be split into two groups that are random. One group will continue metformin in addition to insulin and another group will stop taking metformin when insulin is needed to control their gestational diabetes. Some people may not want to take a pill and a shot and some may want to take a pill if it means taking less medication through shots.
This research questions is important because it will tell us how to better treat gestational diabetes and whether continuing metformin allows us to use less insulin. This could possibly mean less cost for the patient, a better medication schedule (less dose and/or less shots), better blood sugar control, better health benefits for the patient, and/or better health benefits for the baby.
This study is very similar to how current medical practice in obstetrics is currently as some providers continue metformin when insulin is needed and some discontinue it.
This research has not been done in patients with gestational diabetes before in this way. Metformin and insulin have been researched in pregnancy and are both considered standard treatments for gestational diabetes but they have not been researched like this together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Metformin + Insulin | Active comparator | Drug: Metformin + InsulinPregnant women with gestational diabetes who have uncontrolled blood sugar on metformin alone will be started on insulin and will stay on metformin. |
| Insulin | Active comparator | Drug: InsulinPregnant women with gestational diabetes who have uncontrolled blood sugar on metformin along will be started on insulin and metformin will be discontinued. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment
- Ability to take oral medication and be willing to adhere to the metformin regimen
- Willing to take insulin if needed
Key exclusion criteria (1 listed)
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 + InsulinPregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stay on metformin and add insulin. | Drug | Metformin + Insulin |
| InsulinPregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stop on metformin and add insulin. | Drug | Insulin |
Primary outcome
To determine if metformin reduces amount of insulin in patients with gestational diabetes who already require insulin
Time frame: From enrollment into study until delivery, maximum 20 weeks
Insulin dosage (units per kilogram body weight) at last visit prenatal visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- 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.
1 site 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 + Insulin and Insulin in people with Gestational Diabetes, run by University of Virginia at 1 site in United States.
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 7 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda R Urban, MS (4344093100, ajr5y@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if metformin reduces amount of insulin in patients with gestational diabetes who already require insulin (time frame: From enrollment into study until delivery, maximum 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2025.