Myo-inositol for Reduction of Insulin Therapy in Gestational Diabetes Mellitus

NCT03875755 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2020-03-04

Last updated

2025-12-29

Condition(s) studied

Gestational Diabetes Mellitus

Investigational drug(s) / intervention(s)

Myo InositolPlacebo

Myo Inositol: One soft gel capsule containing MI 600 mg and folic acid 200 μg twice a day, until delivery.

Placebo: One soft gel capsule of placebo (folic acid 200 μg) twice a day until delivery.

Study summary

Gestational diabetes mellitus (GDM) is defined as hyperglycemia first-diagnosed during pregnancy. Glycemic control reduces GDM-related complications. With the new diagnostic criteria of GDM, up to 25% of pregnant women have GDM, whereas it was previously 6-10% in France. Therefore caring for women with GDM is very time-consuming. Therapeutic strategy includes dietary and lifestyle measures and additional insulin therapy for 15 to 40% of the women with GDM if the glycemic targets are not achieved after a period of 1 to 2 weeks of diet. Insulin therapy is imperfect for the following main reasons: need for education (i.e. subcutaneous administration, dose titration), hypoglycemia and weight gain, limited acceptance and high cost. Psychosocial deprivation is associated with more cases of GDM and health accessibility may be unequal.

MYO-INOSITOL (MI) is an oral dietary supplement, which reduces insulin resistance. Women with GDM are deficient in MI. MI supplementation safely prevents GDM by 65 to 87% in high-risk women. A pilot study has shown a 75% reduction of the need for insulin during GDM not controlled by diet.

The coordinator investigator propose here, for the first time, a randomized controlled study evaluating MI versus placebo in women with newly diagnosed GDM.

Eligibility

Sex

ALL

Min age

18 Years

Max age

45 Years

Healthy volunteers

Inclusion Criteria: * Age ≥18 years * Singleton pregnancy * GDM diagnosed during pregnancy according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e. * fasting plasma glucose between 92 mg/dL (5.1 mmol/L) and 125 mg/dL (6.9 mmol/L) * and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) ≥ 180 mg/dL (10.0 mmol/L) * and/or 2-hour plasma glucose value between 153 mg/dL (8.5 mmol/L) and 199 mg/dL ((11.0 mmol/L) * or overt diabetes according to 2-hours post OGTT plasma glucose value ≥ 200 mg/dl * 6 to 37 (+6 days) amenorrhea weeks at the time of randomization * Capacity for self-monitoring of blood glucose * Signed informed consent Exclusion Criteria: * Insulin use before randomization during this pregnancy * Use of other oral hypoglycemic agents during this pregnancy * Long time corticosteroid treatment * Pre-existing diabetes before pregnancy * Overt diabetes diagnosed during pregnancy according to fasting plasma glucose ≥ 126 mg/dL (7 mmol/l) * Lack of Social Insurance * Insufficient French understanding and speaking * Participant in another investigational drug study at inclusion visit * Fetal malformation diagnosed by previous fetal ultrasound * Personal history of any bariatric surgery * Hypersensitivity to any ingredient of dietary supplement formulation

Primary outcome measure(s)

Rate of patients requiring insulin therapy during pregnancy — At any time during pregnancy up to delivery; assessed up to 29 weeks.
Rate of patients requiring insulin therapy (either basal or prandial). .

Trial sites (2)

Facility	City	Region	Status
Hôpital Avicenne	Bobigny	France
Hopital Avicenne	Bobigny	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03875755 on ClinicalTrials.gov ↗ ← All trials in France