Status:
TERMINATED
Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Gestational Diabetes Mellitus in Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief 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...
Detailed Description
Phase III study. Prospective, multicenter, non-inferiority, randomized, open-labelled and controlled study with two arms. 1. In the 37 participating hospitals: selection of women with GDM who have un...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT03380546
Start Date
July 4 2018
End Date
February 22 2024
Last Update
July 3 2024
Active Locations (1)
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1
Jean Verdier Hospital
Bondy, France, 93140