Metformin Treatment in Type 2 Diabetes in Pregnancy: An Active Controlled, Parallel-Group, Randomized, Open Label Study in Patients with Type 2 Diabetes in Pregnancy

Abstract

Aims. To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability. Methods. In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma. Results. Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M1"><mml:mo stretchy="false">(</mml:mo><mml:mi>P</mml:mi><mml:mo>&lt;</mml:mo><mml:mn>0.001</mml:mn><mml:mo stretchy="false">)</mml:mo></mml:math>and pregnancy induced hypertension<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M2"><mml:mo stretchy="false">(</mml:mo><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn>0.029</mml:mn><mml:mo stretchy="false">)</mml:mo></mml:math>were observed in metformin treated group. Small for date babies were more in metformin group<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M3"><mml:mo stretchy="false">(</mml:mo><mml:mi>P</mml:mi><mml:mo>&lt;</mml:mo><mml:mn>0.01</mml:mn><mml:mo stretchy="false">)</mml:mo></mml:math>. Neonatal hypoglycemia was significantly less and so was NICU stay of &gt;24 hours in metformin group<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M4"><mml:mo stretchy="false">(</mml:mo><mml:mi>P</mml:mi><mml:mo>&lt;</mml:mo><mml:mn>0.01</mml:mn><mml:mo stretchy="false">)</mml:mo></mml:math>. Significant reduction in cost of treatment was found in metformin group. Conclusion. Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763 .