drugset / Trial / NCT03651531

Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus

NCT03651531

Phase 3 Terminated 1 enrolled Women and Infants Hospital of Rhode Island
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a prospective, unmasked randomized clinical trial comparing the use of insulin vs combination insulin and metformin for treatment in women diagnosed with gestational diabetes mellitus (GDM). The investigator's hypothesis is that the combination of metformin and insulin will be superior to insulin alone to achieve tight glucose control during pregnancy.

Timeline

Start
2018-01-03
Primary completion
2019-07-30
Completion
2019-07-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic 1 iu/kg
Comparator Metformin Small molecule 1000 mg

Indications