Primary objective: To evaluate the effect of treatment with oral hypoglycemic agents (OHA) on the incidence of large-for-gestational-age (LGA) infants in women with GDM requiring medication, compared to insulin (INS) treatment.Secondary objectives:…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure will be large-for-gestational-age (birthweight > 90th
percentile)
Secondary outcome
Secundary outcome measures:
• Maternal hypoglycemia (biochemical hypoglycemia <3.9 mmol/l, symptomatic
hypoglycemia and severe hypoglycemia prompting the need for help by another
person)
• Primary / secondary caesarean section
• Pregnancy related hypertensive disorders: pregnancy induced hypertension,
preeclampsia
• Preterm delivery (<37 weeks of gestation)
• Neonatal hypoglycemia: moderate (serum glucose <2.6 mmol/L), severe (serum
glucose <2.0 mmol/L)
• Neonatal hyperbilirubinemia requiring phototherapy
• Neonatal Medium care / NICU admission
Additional outcome measures:
• Patient satisfaction and health-related quality of life
• Cost effectivity
Background summary
The incidence of gestational diabetes mellitus (GDM) is quickly rising and is
currently complicating approximately 5-10% of all pregnancies in the
Netherlands. This accounts for 13.000 cases each year. GDM carries significant
maternal and perinatal risks such as macrosomia, a large for gestational age
infant, increased risk of caesarean section and other peripartum complications.
In GDM patients, diet adjustment is the first treatment to regulate blood
glucoses. When dietary interventions in GDM fail to normalize blood glucoses,
treatment with antidiabetic medication is indicated. Insulin is the treatment
of choice in the Netherlands. However, insulin treatment is laborious and a
significant burden to both patients and health care resources. Metformin and
glibenclamide are oral hypoglycemic agents. Both have been extensively studied
separately and found to be safe and effective in the treatment of GDM. A
primary treatment strategy with metformin and glibenclamide seems appropriate
but there is no current comparative data with standard treatment in the
Netherlands.
In the SUGAR-DIP trial, a randomised controlled trial, we investigate the
efficacy and safety of oral hypoglycemic agents in a two-step method, starting
with metformin and adding glibenclamide if needed, compared to standard
treatment with insulin in patients with GDM.
Study objective
Primary objective:
To evaluate the effect of treatment with oral hypoglycemic agents (OHA) on the
incidence of large-for-gestational-age (LGA) infants in women with GDM
requiring medication, compared to insulin (INS) treatment.
Secondary objectives:
To study the effect of OHA treatment compared with INS treatment, on maternal
and perinatal outcomes, including maternal glycemic control, pregnancy related
hypertensive disorders, maternal weight gain, premature delivery, birth injury,
neonatal hypoglycemia and neonatal NICU admission.
Additional objective:
To evaluate patient experience and cost-effectiveness of oral hypoglycemic
agents compared to insulin.
Study design
Open label multicenter non-inferiority randomized controlled trial (RCT)
Intervention
Randomization to either treatment with the oral antidiabetic agents (metformin
and if necessary supplemental glibenclamide) or standard treatment with
insulin.
Study burden and risks
Nature and extent of the burden: uring the trial three questionnaires will be
issued to patients. Answering these questionnaires will take approximately
30-40 minutes per questionnaire. Also participants will be asked to record
their glucoses in a diary on a daily basis (routine care) with some additional
quiestions (1-2 minutes extra)
Risks: treatment of gestational diabetes with either metformin or glibenclamide
has been investigated worldwide and proven to be safe.
Benefit: women treated with oral antidiabetic agents may achieve adequate
glucose control with the benefit of a better tolerated and less invasive
administration of medication.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Inclusion 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
Exclusion criteria
- 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
* * e.g. hypersensitivity to glibenclamide / metformin or to any of the
excipients, hypersensitivity to other sulphonylureas, history of ketoacidosis,
impaired adrenal function, severe infection
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | 6134 |
| EudraCT | EUCTR2016-001401-16-NL |
| CCMO | NL57195.041.16 |