PERINATAL TRIALS REPORT

PT0521

Gestational diabetes: treatment with metformin compared with insulin

Plain Language Summary:      Metformin has been used to treat women with gestational diabetes in some countries for 30 years and has potential advantages over conventional treatment with insulin. Data support safety with metformin in pregnancy, but there are no prospective randomised data to determine its role in treatment of women with gestational diabetes. This study aims to show for women with gestational diabetes metformin treatment compared with insulin will show similar perinatal outcomes, improve insulin sensitivity in the mother and baby and be associated with improved treatment acceptability.

Trial status:                         Open to accrual

Date trial opened to accrual:    2002

Expected accrual period:         3 years

Trial Objective:

The primary objective is to compare efficacy of metformin with insulin for the treatment of gestational diabetes mellitus, within a prospective randomised trial.

Type of administration:        Multi-centre International

Prinicipal Investigator/s:     Dr Janet Rowen

                                        Ph 64 9 6389909

                                        Email jrowen@internet.co.nz

                                        Dr William Hague

                                        Ph 61 8 8269 6900

                                        Email bill.hague@adelaide.edu.au

Contact Person/s:             Dr Janet Rowen

                                       As above.

© IMPACT/PSANZ 2001