Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

• \-

Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Amanda R Urban, MS
ajr5y@uvahealth.org
4344093100
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 130
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov