GDM: Insulin with or Without Metformin?

NCT06781775 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 231576
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment into study until delivery, maximum 20 weeks

Study Arms (2)

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.

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.

Drug: Insulin

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.

Metformin + 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.

Insulin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Metformin; Insulin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Amanda R Urban, MS

CONTACT

4344093100; ajr5y@uvahealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Maternal Fetal Medicine

Model Details: Randomized control trial

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: January 17, 2025
• Study Start: December 12, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)