The SUGAR-DIP trial: Oral medication versus insulin for diabetes in pregnancy

Phase 1

• Conditions: The medical condition to be investigated in this trial is gestational diabetes with insufficient glycemic control by means of dietary adjustments and thus an indication for addiotional pharmacological treatment.; MedDRA version: 20.0 Level: PT Classification code 10018209 Term: Gestational diabetes System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2016-001401-16-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-23
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 810

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Aged 18 years or over
- Singleton pregnancy
- Diagnosis of GDM as per national guidelines
- Indication for pharmacological treatment of GDM
- Gestational age between 16 and 34 weeks
- Ability to understand Dutch or English
- Ability to provide written 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 810
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from the study:
- Known pre-existent type 1 or type 2 diabetes mellitus
- Severe medical or psychiatric comorbidities
- Serious liver disease or kidney failure, or any other condition with contraindications for the use of either metformin or glibenclamide
- Pregnancy with a fetus affected by major congenital birth defects and/or chromosomal abnormalities

Study & Design

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