A major clinical trial launching in Brazil aims to evaluate metformin as an alternative to insulin for managing gestational diabetes mellitus (GDM), addressing a critical healthcare need in low and middle-income countries. The Metformin versus Insulin in Glycemic Control in Pregnancy (MevIP) study will be conducted at the Women's Hospital of the State University of Campinas.
Study Design and Patient Population
The open-label randomized controlled trial will enroll 92 pregnant women with either type II diabetes mellitus or GDM requiring medication for glycemic control. Participants will be randomized in a 1:1 ratio to receive either metformin or insulin therapy before 34 weeks of gestation.
"Given Brazil's socioeconomic reality and metformin's demonstrated safety in previous trials, we expect this study will establish metformin as an adequate and appropriate medication for GDM treatment in our population," the research team states.
Clinical Significance and Treatment Protocol
The trial addresses a significant public health challenge in Brazil, where GDM affects approximately 18% of pregnancies. The initial metformin dosage will be 500 mg/day, while the insulin group will start with 6-10 units daily. Dosages will be adjusted based on glycemic control, with additional medication added if patients require over 2g/day of metformin or 80 units of insulin.
Primary and Secondary Outcomes
The study's primary endpoint is glycemic control, defined as fasting glucose under 95 mg/dL and post-meal levels under 140 mg/dL. Secondary outcomes include:
- Gestational weight gain
- Incidence of hypertensive disorders
- Fetal growth patterns
- Neonatal intensive care requirements
- Occurrence of neonatal hypoglycemia
Economic and Accessibility Considerations
The trial particularly considers the practical aspects of diabetes management in low and middle-income settings. Metformin offers several advantages over insulin, including:
- Lower cost
- Easier storage requirements
- Simpler administration
- Better potential for treatment adherence
Patient Monitoring and Safety
Participants will undergo comprehensive monitoring, including:
- Minimum of 10 medical appointments
- Trimesterly ultrasound examinations
- Regular blood glucose self-monitoring
- Weekly cardiotocography after 32 weeks
- Daily fetal movement counting
The study protocol includes strict safety monitoring and clear criteria for treatment modification or discontinuation. The research team will conduct interim analyses after every thirty patients to ensure patient safety and treatment efficacy.
