A phase three open label randomized controlled trial to compare the efficacy of oral hypoglycemic agents (OHA) with insulin in the treatment of gestational diabetes mellitus (GDM)
Location
Auditorium Pond Side
Start Date
26-2-2014 10:30 AM
Abstract
Background: The incidence of GDM is 1 – 14 % (5 – 8 % reported in most areas). It is globally on the rise in parallel with type 2 diabetes. The short and long term adverse maternal, fetal and neonatal outcomes in pregnancy with Diabetes are well known. Insulin therapy has been regarded as the gold standard medical intervention in pregnancy. It has limitations especially in poorly resourced, illiterate and non-compliant population. Studies have shown that some oral hypoglycemic agents (OHA) ( FDA category B:Glibenclamide and Metformin) are safe in pregnancy. Studies comparing these with insulin have found them to be as effective as insulin with comparable outcomes in pregnancy.
Objectives: Primary objective:To compare efficacy of Oral Hypoglycemic Agents and Insulin in the treatment of GDM (percentage of subjects achieving target blood sugars at delivery).
Secondary objective :To compare cost and acceptability to treatment in both groups.
Methods: This is a collaborative study between the Department of Obstetrics and Gynaecology and the Section of Endocrinology, Department of Medicine.
Results and conclusions: This clinical trial is in progress and is recruiting patients. Results will be communicated later on
A phase three open label randomized controlled trial to compare the efficacy of oral hypoglycemic agents (OHA) with insulin in the treatment of gestational diabetes mellitus (GDM)
Auditorium Pond Side
Background: The incidence of GDM is 1 – 14 % (5 – 8 % reported in most areas). It is globally on the rise in parallel with type 2 diabetes. The short and long term adverse maternal, fetal and neonatal outcomes in pregnancy with Diabetes are well known. Insulin therapy has been regarded as the gold standard medical intervention in pregnancy. It has limitations especially in poorly resourced, illiterate and non-compliant population. Studies have shown that some oral hypoglycemic agents (OHA) ( FDA category B:Glibenclamide and Metformin) are safe in pregnancy. Studies comparing these with insulin have found them to be as effective as insulin with comparable outcomes in pregnancy.
Objectives: Primary objective:To compare efficacy of Oral Hypoglycemic Agents and Insulin in the treatment of GDM (percentage of subjects achieving target blood sugars at delivery).
Secondary objective :To compare cost and acceptability to treatment in both groups.
Methods: This is a collaborative study between the Department of Obstetrics and Gynaecology and the Section of Endocrinology, Department of Medicine.
Results and conclusions: This clinical trial is in progress and is recruiting patients. Results will be communicated later on