on-inferiority Between Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial

Phase 1

• Conditions: Pregnant women with Gestational Diabetes Mellitus (GDM); MedDRA version: 19.0Level: PTClassification code 10018209Term: Gestational diabetesSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-001986-10-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-18
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1780

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

- 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<50%)
- Long time corticosteroids treatment
- Pre-existing diabetes in pregnancy
- Overt diabetes diagnosed during pregnancy:
o fasting plasma glucose > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>B. To compare the acarbose arm and the prandial insulin arm on maternal and neonatal complications<br>C. To test the acceptance/satisfaction of the two strategies <br>D. To compare the acarbose and insulin on side effects<br>E. To evaluate maternal and offspring short term follow-up (3 months after delivery) <br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): A. Capillary glucose levels / Need for prandial insulin in the acarbose arm / Need for basal insulin<br>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<br>C. Quality of life / satisfaction questionnaires<br>D. Gestational weight gain / Hypoglycemia / Gastro-intestinal side effects<br>E. Results of oral glucose tolerance test / Weight changes 3 months after delivery<br>F. Future biochemical measurements;Timepoint(s) of evaluation of this end point: Birth and 12 to 16 weeks after delivery