GDM: Insulin with or Without Metformin?

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06781775
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin + Insulin — DRUG
    Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stay on metformin and add insulin.
  • Insulin — DRUG
    Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stop on metformin and add insulin.

Study Details

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.

Key Dates

Start date
Dec 12, 2024
Status verified
Dec 2024
Primary completion
May 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Amanda Urban
[email protected]
4344093100
Christopher Ennen, MD

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University of Virginia· Charlottesville, VA

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