Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus.

• Status: Recruiting
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Acarbose; Insulin; Insulin, Globin Zinc; Insulin, Short-Acting

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Singleton pregnancy

• GDM diagnosed during pregnancy according to IADPSG criteria

• Self-monitoring of blood glucose

• After at least 7 days of dietary and lifestyle measures, unreached post-prandial glucose control

• 14-37 (+ 6 days) amenorrhea weeks at the time of randomization

• Signed informed consent

Exclusion Criteria:

• Prandial insulin use before randomization during this pregnancy

• Use of other oral hypoglycemic agents during this pregnancy

• Multiple pregnancy

• Known hepatic insufficiency

• Long time corticosteroid treatment

• Pre-existing diabetes in pregnancy

• Overt diabetes diagnosed during pregnancy (IADPSG criteria)

• Lack of Social Insurance

• Insufficient understanding

• Participant in another investigational drug study at inclusion visit

• Contraindications of acarbose

• Fetal malformation diagnosed by previous fetal ultrasound