Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus.
Status:
Recruiting
Trial end date:
2022-03-30
Target enrollment:
Participant gender:
Summary
Caring for women with gestational diabetes mellitus (GDM) is very time-consuming. Therapeutic
strategy includes dietary and lifestyle measures and additional insulin therapy for 15 to 40%
of the women with GDM if the glycemic targets are not achieved after a period of 1 to 2 weeks
of diet. Insulin therapy is imperfect for the following main reasons: need for education
(i.e. subcutaneous administration, dose titration), hypoglycemia and weight gain, limited
acceptance and high cost. Psychosocial deprivation is associated with more cases of GDM and
health accessibility may be unequal.
Glucosidase inhibitors (acarbose) reduce intestinal absorption of starch and reduce the rate
of complex carbohydrate digestion. It mainly lowers postprandial glucose values and is used
in type 2 diabetes for a long time. Less than 2% of a dose is absorbed as active drug in
adults, with 34% of the metabolites found in the systemic circulation. Doses of up to 9 and
32 times the human dose were not teratogenic in pregnant rats or rabbits. Limited but
reassuring data during pregnancy are available. Acarbose was well tolerated (little
gestational weight gain, no hypoglycemia) with digestive discomfort in some women, balanced
by treatment satisfaction as compared with insulin injections. Our hypothesis is that
treatment aiming to control postprandial glucose values with acarbose as compared with
prandial insulin injection will be as efficient and safe, but more convenient and less
expensive.