Recruiting

Insulin with Metformin

Sponsor:

University of Virginia

Code:

NCT06781775

Conditions

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Metformin + Insulin

Insulin

Study Details

Brief 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. The investigators hypothesize that continuing metformin will reduce the needed insulin dosage and improve maternal and neonatal outcomes in these patients.

Conditions

Gestational Diabetes

Study ID

NCT06781775

Start date

Dec 12, 2024

Status verified date

Dec, 2024

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment
4. Ability to take oral medication and be willing to adhere to the metformin regimen
5. Willing to take insulin if needed
6. Willing to take blood sugars 4 times per day

-

Exclusion Criteria:
  • 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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Metformin + Insulin

Pregnant women with gestational diabetes who have uncontrolled blood sugar on metformin alone will be started on insulin and will stay on metformin.

active comparator: Insulin

Pregnant women with gestational diabetes who have uncontrolled blood sugar on metformin along will be started on insulin and metformin will be discontinued.

Interventions

Metformin + Insulin

Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stay on metformin and add insulin.

Insulin

Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stop on metformin and add insulin.

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 ]

Central Contacts and Locations

Central contacts

Amanda R Urban, MS

4344093100ajr5y@uvahealth.org

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Amanda Urban

4344093100ajr5y@uvahealth.org

More Information

Sponsor

University of Virginia

Last update posted

Jan 17, 2025

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-01-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.