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

Gestational Diabetes Clinical Trial

Official title: Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus

Status Terminated

Clinical Trial 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.

Clinical Trial Description

The objective of this study is to compare the effectiveness of insulin alone vs the combination of insulin and metformin in treating patients with gestational diabetes (GDM). Currently, outside of pregnancy, the treatment of type 2 diabetes mellitus (T2DM) with both metformin and insulin is superior to using insulin alone. In pregnancy, insulin alone has traditionally been used, though some advocate the use of metformin alone as primary therapy. There have been no trials published to date specifically comparing combination therapy to insulin alone. Our hypothesis is that the combination of metformin and insulin will improve overall control of blood glucose, the improvement of which has been demonstrated to improve maternal and neonatal outcomes. Control of blood glucose will be determined by hemoglobin A1c at the time of delivery. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

• NCT number: NCT03651531
• Study type: Interventional
• Source: Women and Infants Hospital of Rhode Island
• Status: Terminated
• Phase: Phase 3
• Start date: January 3, 2018
• Completion date: July 30, 2019