Pregnant women with Gestational Diabetes Mellitus (GDM) MedDRA version: 19.0 Level: PT Classification code 10018209 Term: Gestational diabetes System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Acarbose
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Solut
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age > ou = 18 years - Singleton pregnancy - GDM diagnosed during pregnancy according to IADPSG criteria, i. e. o fasting plasma glucose between 92 mg/dL (5.1 mmol/L) and 125 mg/dL (6.9 mmol/L) o and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) o > ou = 180 mg/dL (10.0 mmol/L) o and/or 2-hour plasma glucose value between 153 mg/dL (8.5 mmol/L) and 199 mg/dL ((11.0 mmol/L) - Self-monitoring of blood glucose - After at least 7 days of dietary and lifestyle measures, unreached post-prandial glucose control (at least two capillary 2-hour post-prandial glucose values >1.20 g/l ((6.6 mmol/L)) - 12 to 34 weeks of gestation at the time of randomization - Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1780 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Prandial insulin use before randomization during this pregnancy - Use of other oral hypoglycemic agents during this pregnancy - Multiple pregnancy - Known hepatic insufficiency (bilirubin > 50 µmol/L and/or TP ou = 126 mg/dL (7 mmol/l) o and/or 2-hour post OGTT plasma glucose value ? 200 mg/dL (11.1 mmol/L) - Lack of Social Insurance - Insufficient understanding - Participant in another investigational drug study at inclusion visit - Contraindications of acarbose: o documented hypersensitivity to acarbose o diabetic ketoacidosis o cirrhosis o inflammatory bowel disease o colonic ulceration, partial intestinal obstruction or predisposed to intestinal obstruction o known marked absorptive impairment o known renal impairment (creatinine clearance < 25 ml/min) -fetal malformation diagnosed by previous fetal ultrasound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test whether oral acarbose is non-inferior to subcutaneous prandial insulin for the occurrence of perinatal complications in the management of pregnant women developing GDM and requiring treatment other than diet to control post-prandial glucose values. ;Secondary Objective: A. To compare the two treatment strategies on maternal glycaemic control B. To compare the acarbose arm and the prandial insulin arm on maternal and neonatal complications C. To test the acceptance/satisfaction of the two strategies D. To compare the acarbose and insulin on side effects E. To evaluate maternal and offspring short term follow-up (3 months after delivery) F. Conservation of serum and cord fluid at the time of delivery;Primary end point(s): Composite endpoint: birth weight = 90th percentile for gestational age (large for gestational age: LGA) and/or neonatal hypoglycemia and/or shoulder dystocia and/or birth injury;Timepoint(s) of evaluation of this end point: Birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A. Capillary glucose levels / Need for prandial insulin in the acarbose arm / Need for basal insulin B. Birth weight = 4000g / Birth weight = 4500g / Preeclampsia / Pregnancy-induced hypertension / Cesarean section / Maternal inpatient admission during pregnancy / Preterm delivery (<37 gestation weeks) / Extreme prematurity (<32 gestation weeks) / 5-min Apgar score / Phototherapy / Neonatal respiratory distress syndrome / Intrauterine fetal or neonatal death / Admission to neonatal intensive care unit / Malformations C. Quality of life / satisfaction questionnaires D. Gestational weight gain / Hypoglycemia / Gastro-intestinal side effects E. Results of oral glucose tolerance test / Weight changes 3 months after delivery F. Future biochemical measurements;Timepoint(s) of evaluation of this end point: Birth and 12 to 16 weeks after delivery | — |
Countries
France
Contacts
Public ContactDRCD Hôpital St Louis, Elodie SOLER
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed