CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 221 enrolled
Drug / intervention
metformin +1 moredrug
Likely dose
metformin 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01240785
NCT01240785Phase 4Completed
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Metformin Versus Insulin in Gestational Diabetes. A Randomized Controlled Single Center Trial.

Turku University Hospital·interventional·Posted Nov 15, 2010·Updated Nov 24, 2014

In Brief

A Phase 4 clinical trial evaluating metformin and insulin for Gestational Diabetes. Completed, enrolled 221 participants.

Detailed Summary

Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGestational Diabetes
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 15, 2010
Enrollment StartJun 1, 2006
Primary CompletionJan 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 15.6 years ago

Interventions

metformindrug

metformin 1 g twice daily or maximum tolerated dose less than 2 g daily

insulindrug

subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery