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

NCT03875755 | Active Not Recruiting DMC

• 1 other identifier: P160940J
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Gestational Diabetes Mellitus

Keywords

Diabetes; Pregnancy; MYO-INOSITOL; Oral supplementation

Outcome Measures

Primary Outcomes (1)

• Rate of patients requiring insulin therapy during pregnancy

  Rate of patients requiring insulin therapy (either basal or prandial). .

  At any time during pregnancy up to delivery; assessed up to 29 weeks.

Secondary Outcomes (11)

• - Rate of patients requiring basal insulin therapy during pregnancy- /Rate of patients requiring prandial insulin therapy during pregnancy

  At any time during pregnancy up to delivery; assessed up to 29 weeks.

• - Doses of basal and prandial insulin at delivery- Gestation age when insulin is began - Duration of insulin treatment

  At delivery; assessed up to 29 weeks.

• Gestational weight gain

  At any time during pregnancy up to delivery; assessed up to 29 weeks.

• Hypoglycemia

  from randomization to delivery; assessed up to 29 weeks.

• Capillary glucose levels

  From the beginning of MI Supplementation to delivery;assessed up to 29 weeks.

Study Arms (2)

Myo Inositol

EXPERIMENTAL

The women will receive 2 caps of Myo Inositol with acid folic a day, until delivery

Dietary Supplement: Myo Inositol

Placebo

PLACEBO COMPARATOR

The women will receive 2 caps of placebo (acid folic) a day, until delivery

Other: Placebo

Interventions

Myo Inositol DIETARY_SUPPLEMENT

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

Also known as: INOFOLIC

Myo Inositol

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The participants in this study are pregnant women with gestational diabetes mellitus.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• to 37 (+6 days) amenorrhea weeks at the time of randomization
• Capacity for self-monitoring of blood glucose
• Signed informed consent

You may not qualify if:

• 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
• Fetal malformation diagnosed by previous fetal ultrasound
• Personal history of any bariatric surgery
• Hypersensitivity to any ingredient of dietary supplement formulation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Avicenne

Bobigny, 93000, France

Location

Hopital Avicenne

Bobigny, France

Location

Related Publications (8)

• Croze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10.

  PMID: 23764390 BACKGROUND

• Unfer V, Carlomagno G, Dante G, Facchinetti F. Effects of myo-inositol in women with PCOS: a systematic review of randomized controlled trials. Gynecol Endocrinol. 2012 Jul;28(7):509-15. doi: 10.3109/09513590.2011.650660. Epub 2012 Feb 1.

  PMID: 22296306 BACKGROUND

• Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x.

  PMID: 21414183 BACKGROUND

• D'Anna R, Di Benedetto V, Rizzo P, Raffone E, Interdonato ML, Corrado F, Di Benedetto A. Myo-inositol may prevent gestational diabetes in PCOS women. Gynecol Endocrinol. 2012 Jun;28(6):440-2. doi: 10.3109/09513590.2011.633665. Epub 2011 Nov 28.

  PMID: 22122627 BACKGROUND

• Matarrelli B, Vitacolonna E, D'Angelo M, Pavone G, Mattei PA, Liberati M, Celentano C. Effect of dietary myo-inositol supplementation in pregnancy on the incidence of maternal gestational diabetes mellitus and fetal outcomes: a randomized controlled trial. J Matern Fetal Neonatal Med. 2013 Jul;26(10):967-72. doi: 10.3109/14767058.2013.766691. Epub 2013 Mar 1.

  PMID: 23327487 BACKGROUND

• D'Anna R, Scilipoti A, Giordano D, Caruso C, Cannata ML, Interdonato ML, Corrado F, Di Benedetto A. myo-Inositol supplementation and onset of gestational diabetes mellitus in pregnant women with a family history of type 2 diabetes: a prospective, randomized, placebo-controlled study. Diabetes Care. 2013 Apr;36(4):854-7. doi: 10.2337/dc12-1371. Epub 2013 Jan 22.

  PMID: 23340885 BACKGROUND

• D'Anna R, Di Benedetto A, Scilipoti A, Santamaria A, Interdonato ML, Petrella E, Neri I, Pintaudi B, Corrado F, Facchinetti F. Myo-inositol Supplementation for Prevention of Gestational Diabetes in Obese Pregnant Women: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):310-315. doi: 10.1097/AOG.0000000000000958.

  PMID: 26241420 BACKGROUND

• Lubin V, Shojai R, Darmon P, Cosson E. A pilot study of gestational diabetes mellitus not controlled by diet alone: First-line medical treatment with myoinositol may limit the need for insulin. Diabetes Metab. 2016 Jun;42(3):192-5. doi: 10.1016/j.diabet.2016.01.005.

  PMID: 26948394 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus

Interventions

Inositol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Emmanuel COSSON, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: March 15, 2019
• Study Start: March 4, 2020
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)