Gestational Diabetes MellitusMYO-GDMNCT03875755
Myo-inositol for Reduction of Insulin Therapy in Gestational Diabetes Mellitus
A study testing Myo Inositol in people with Gestational Diabetes Mellitus, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Myo Inositol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,080 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Mar 2020to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Reduction of Insulin Therapy Under Myo-inositol for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. MYO-GDM Study
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.
Read the detailed description
Prospective, multicenter, superiority, randomised, double blind study with two arms.
- In the 23 participating centers selection of women with GDM between 6 to 37 (+6 days) amenorrhea weeks
- Explanation of protocol, with signature of consent in case of acceptation.
- Randomization
- Experimental group: The women will receive 2 caps of MI with acid folic a day, until delivery
- Control group: The women will receive 2 caps of placebo (containing only acid folic) a day, until delivery In both arms, the participants will be routinely followed up during pregnancy:
- diet education,
- self-monitoring of blood glucose before and after meals
- and during follow-up insulin therapy if glucose value targets are unmet
- Routine monitoring of the women with GDM in both arms, up to delivery, without use of other oral hypoglycemic agents during pregnancy. At delivery:
- MI (or placebo) will be stopped
- Events during pregnancy will be collected
- Last visit three months after delivery. Oral glucose tolerance test, anthropometric measures for women and their child.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Myo Inositol, Placebo
- Keywords
- Diabetes, Pregnancy, MYO-INOSITOL, Oral supplementation
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo InositolDietary supplement
Also called INOFOLIC
One soft gel capsule containing MI 600 mg and folic acid 200 μg twice a day, until delivery.
PlaceboOther
One soft gel capsule of placebo (folic acid 200 μg) twice a day until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Myo Inositol | Experimental | The women will receive 2 caps of Myo Inositol with acid folic a day, until delivery Receives: Dietary Supplement: Myo Inositol |
| Placebo | Placebo comparator | The women will receive 2 caps of placebo (acid folic) a day, until delivery Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients requiring insulin therapy during pregnancy
Rate of patients requiring insulin therapy (either basal or prandial). .
Measured: 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
This information will be retrieved from the glucose meter, and if not available, from the woman's diary
Measured: 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
- Dose of basal insulin (UI) at delivery, if any
- Dose of prandial insulin (UI) at delivery, if any
- Gestational age (SA) when basal insulin is started.
- Gestational age (SA) when prandial insulin is started
- Duration of basal insulin treatment at delivery, if any
- Duration of prandial insulin treatment at delivery, if any
Measured: At delivery; assessed up to 29 weeks.
Gestational weight gain
- Gestational weight gain (Kg) during pregnancy
- Gestational weight gain (Kg) between inclusion and delivery
Measured: At any time during pregnancy up to delivery; assessed up to 29 weeks.
Hypoglycemia
- Severe hypoglycemia: requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Plasma Glucose concentrations may not be available during an event, but neurological recovery following the return of plasma/capillary glucose to normal is considered sufficient evidence that the event was induced by a low plasma/capillary glucose concentration.
- Documented symptomatic hypoglycemia: event during which typical symptoms of hypoglycemia are accompanied by a measured capillary glucose concentration <70 mg/dL (<3.9 mmol/L).
- Asymptomatic hypoglycemia: event not accompanied by typical symptoms of hypoglycemia but with a measured capillary glucose concentration <60 mg/dL (<3.3 mmol/L).
Measured: from randomization to delivery; assessed up to 29 weeks.
Capillary glucose levels
The women will be asked to perform 6 measures a day. Capillary glucose values will be retrieved from the glucose meter, and if not available, from the woman's diary.
Measured: From the beginning of MI Supplementation to delivery;assessed up to 29 weeks.
Neonatal complications
- Birth weight ≥ 4000g; ≥ 4500g ; large and small for gestational age infant
- Neonatal hypoglycemia defined as at least a blood glucose value lower than 2.0 mmol/l after 2 hours of life during the two first days of life if the newborn is asymptomatic
- Shoulder dystocia, defined as vaginal cephalic delivery
- Birth injury defined as plexus injury or clavicle fracture
- Preterm delivery:
- Late preterm infant (between 32 and 37 completed amenorrhea weeks)
- Very preterm infant (28-31 completed amenorrhea weeks)
- Extreme preterm infant (less than 28 completed amenorrhea weeks)
- Low Apgar score: 5-min Apgar score < 7• Jaundice, defined as need for neonatal phototherapy • Neonatal respiratory distress syndrome, based on the clinical course, chest X-ray finding, blood gas and acid-base values • Medical need for admission to pediatric or neonatal intensive care unit during the three days following birth • Malformations: the types of malformation will be recorded.
Measured: At delivery; assessed up to 29 weeks
Preeclampsia - Pregnancy-induced hypertension - Cesarean section - Maternal inpatient admission during pregnancy
- Preeclampsia (blood pressure ≥ 140/90 mmHg on two measurements four hours apart and proteinuria of at least 300 mg/24 hours or 3+ or more on dipstick testing or proteinuria/creatinuria >30 in a random urine sample)
- Pregnancy-induced hypertension: in women with no known hypertension before pregnancy, blood pressure ≥ 140/90 mmHg on two measurements four hours apart without proteinuria and having needed to begin anti-hypertensive therapy
- Maternal inpatient admission during pregnancy after inclusion, not including hospitalization just after delivery
Measured: At any time during pregnancy up to delivery; assessed up to 29 weeks.
Side effects
The investigators expect MI not to have any side effect at the dose 1200 mg/day, but possible side effects will be collected.
Measured: From the beginning of MI Supplementation to delivery; assessed up to 29 weeks.
Results of oral glucose tolerance test
Test will be performed by the women 3 months post partum
Measured: 3 months after delivery
Infant anthropometrics.
These data will be collected from children's health record
Measured: At month 1, month 2 and month 3
Acceptance/satisfaction of 2 strategies: score
Evaluation of the patient's satisfaction about their treatment for GDM at delivery : give a score of 0 to 100: 0 not satisfied; 100 totally satisfied
Measured: At delivery; assessed up to 29 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start4 Mar 2020
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel COSSON, MD-PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875755
- Sponsor's protocol ID
- P160940J
- Acronym
- MYO-GDM
- Status last verified
- Dec 2025
- First submitted
- 25 Jan 2019
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23764390Unfer 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.
PubMed 22296306Corrado 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.
PubMed 21414183D'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.
PubMed 22122627Matarrelli 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.
PubMed 23327487D'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.
PubMed 23340885D'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.
PubMed 26241420Lubin 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.
PubMed 26948394
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Insulin Therapy Under Myo-inositol for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. MYO-GDM Study
- ClinicalTrials.gov ID
- NCT03875755
- Acronym / sponsor ID
- MYO-GDM / P160940J
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Diabetes, Pregnancy, MYO-INOSITOL, Oral supplementation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective, multicenter, superiority, randomised, double blind study with two arms.
- In the 23 participating centers selection of women with GDM between 6 to 37 (+6 days) amenorrhea weeks
- Explanation of protocol, with signature of consent in case of acceptation.
- Randomization
- Experimental group: The women will receive 2 caps of MI with acid folic a day, until delivery
- Control group: The women will receive 2 caps of placebo (containing only acid folic) a day, until delivery In both arms, the participants will be routinely followed up during pregnancy:
- diet education,
- self-monitoring of blood glucose before and after meals
- and during follow-up insulin therapy if glucose value targets are unmet
- Routine monitoring of the women with GDM in both arms, up to delivery, without use of other oral hypoglycemic agents during pregnancy. At delivery:
- MI (or placebo) will be stopped
- Events during pregnancy will be collected
- Last visit three months after delivery. Oral glucose tolerance test, anthropometric measures for women and their child.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myo Inositol | Experimental | Dietary Supplement: Myo InositolThe women will receive 2 caps of Myo Inositol with acid folic a day, until delivery |
| Placebo | Placebo comparator | Other: PlaceboThe women will receive 2 caps of placebo (acid folic) a day, until delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age ≥18 years
- Singleton pregnancy
- GDM diagnosed during pregnancy according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e.
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myo InositolAlso: INOFOLICOne soft gel capsule containing MI 600 mg and folic acid 200 μg twice a day, until delivery. | Dietary supplement | Myo Inositol |
| PlaceboOne soft gel capsule of placebo (folic acid 200 μg) twice a day until delivery. | Other | Placebo |
Primary outcome
Rate of patients requiring insulin therapy during pregnancy
Time frame: At any time during pregnancy up to delivery; assessed up to 29 weeks.
Rate of patients requiring insulin therapy (either basal or prandial). .
11 secondary outcomes
- Rate of patients requiring basal insulin therapy during pregnancy- /Rate of patients requiring prandial insulin therapy during pregnancy
Time frame: 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
Time frame: At delivery; assessed up to 29 weeks.
Gestational weight gain
Time frame: At any time during pregnancy up to delivery; assessed up to 29 weeks.
Hypoglycemia
Time frame: from randomization to delivery; assessed up to 29 weeks.
Capillary glucose levels
Time frame: From the beginning of MI Supplementation to delivery;assessed up to 29 weeks.
Neonatal complications
Time frame: At delivery; assessed up to 29 weeks
Preeclampsia - Pregnancy-induced hypertension - Cesarean section - Maternal inpatient admission during pregnancy
Time frame: At any time during pregnancy up to delivery; assessed up to 29 weeks.
Side effects
Time frame: From the beginning of MI Supplementation to delivery; assessed up to 29 weeks.
Results of oral glucose tolerance test
Time frame: 3 months after delivery
Infant anthropometrics.
Time frame: At month 1, month 2 and month 3
Acceptance/satisfaction of 2 strategies: score
Time frame: At delivery; assessed up to 29 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 23764390Croze 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.
- Background: PubMed 22296306Unfer 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.
- Background: PubMed 21414183Corrado 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.
- Background: PubMed 22122627D'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.
- Background: PubMed 23327487Matarrelli 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.
- Background: PubMed 23340885D'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.
- Background: PubMed 26241420D'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.
- Background: PubMed 26948394Lubin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel COSSON, MD-PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myo Inositol in people with Gestational Diabetes Mellitus, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients requiring insulin therapy during pregnancy (time frame: At any time during pregnancy up to delivery; assessed up to 29 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03875755, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.