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The Capital Region of Denmark - a part of Copenhagen University Hospital

The impact of liraglutide on glucose tolerance and the risk of type 2 diabetes in women with previous gestational diabetes mellitus

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Introduction

The incidence of type 2 diabetes mellitus is increasing, however, as the disease is often asymptomatic in the early stages, many patients are undiagnosed, and the pathophysiology in the early stages is poorly understood. Pregnancy is associated with decreased insulin sensitivity, which is usually overcome by increased insulin secretion. However, some women are not able to increase the insulin secretion sufficiently, and consequently, develop gestational diabetes (GDM). The disease often disappears after delivery. However, these women are at high risk of developing type 2 diabetes later in life. Hence, this high-risk group of patients provides a unique opportunity for studying both the beta cell protective effects of GLP-1 analogues, and the development of type 2 diabetes in order to determine what clinical and physiological factors predict and/or attend the development of diabetes.

Trial design

One hundred women with previous GDM will be randomised to either liraglutide or placebo-treatment for one year (double-blinded), and the liraglutide-group will continue on their trial medication for four more years, open-label. Women will be tested with an oral glucose tolerance test (OGTT) and isoglycaemic intravenous glucose infusion (IIGI), which matches the plasma glucose on the OGTT-day, at baseline, after one year, and after five years. OGTT will also be carried out after one week of wash-out. Primary endpoint of investigation will be changes in the glucose tolerance from baseline to week 52 as measured by area under the curve (AUC) for the PG excursion during the OGTT.

StatusCurrent
Period01/10/2012 → …

ID: 36419172