Gestational Diabetes MellitusGEM GDMNCT03610178
Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus
A study testing Very tight glycemic targets, life-style modification, insulin therapy if needed and Tight-moderate glycemic targets, life-style modification, insulin therapy if needed in people with Gestational Diabetes Mellitus, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
Trial summary
This is a randomized controlled trial of different glycemic targets during tratment of women with GDM with assessement of epygenetic aspects of their effects on the fetus and pregnancy outcomes. This study is interventional, randomised controlled trial, open-label. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Very tight glycemic targets, life-style modification, insulin therapy if needed and Tight-moderate glycemic targets, life-style modification, insulin therapy if needed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteRussia
- Study dates
- Aug 2015to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women with GDM diagnosed according to the Russian national consensus and the recommendations of the International Association of Diabetes and Pregnancy Study Groups (fasting glucose of ≥5.1 mmol/L, and/or ≥10.0 mmol/L after 1 h, and/or ≥8.5 mmol/L after 2 h in oral glucose tolerance test (OGTT) with 75 g of glucose).
- Gestational age at the time of inclusion in the study 12 weeks 0 days - 31 weeks 6 days
- For control group: pregnant women with normal glucose tolerance confirmed by OGTT at 24-31 weeks of gestation.
Who cannot join
- Diabetes mellitus type 1 and tipe 2
- Other deseases that affect methabolism of carbohydrates
- Use of drugs that affect methabolism of carbohydrates
- Malformations of the fetus identifired prior to inclusion to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus: a Randomised Controlled Trial of Different Glycemic Targets During Pregnancy
This is a randomized controlled trial of different glycemic targets during tratment of women with GDM with assessement of epygenetic aspects of their effects on the fetus and pregnancy outcomes. This study is interventional, randomised controlled trial, open-label.
Read the detailed description
The study aims to clarify the effect of hyperglycemia and its correction, the level of physical activity and consumption of major macro- and micronutrients by women during pregnancy on DNA methylation and expression of genes involved in neuroendocrine regulation and development of metabolic diseases in offspring, as well as functional characteristics of human umbilical vein endothelial cells (HUVECs). For the purpose of the study women with GDM are randomised to 2 treatment groups per glycemic targets ( very tight and tight-moderate glycemic targets). Data on glycenmic levels during the study and consumption of major macro- and micronutrients will be collected using a mobile application with electronic dairies report forms.
This clinical trial record primarily describes the overarching observational cohort study "Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus" including women with GDM and healthy pregnant women.
Substudy Protocol: A key predefined component of this larger study is an interventional, randomized controlled substudy entitled "Tight versus less tight glycaemic targets for women with gestational diabetes mellitus: a randomised controlled trial" (also known as the GEM GDM Trial).
The GEM GDM Trial is an open-label, randomized controlled trial (RCT) that compares the effects of tight (very tight) versus less tight (tight-moderate) glycemic control on maternal and neonatal outcomes in women diagnosed with Gestational Diabetes Mellitus (GDM). Participants from the main GEM cohort who are diagnosed with GDM according to International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria are eligible for screening and subsequent randomization into this substudy.
The substudy aims to enroll 650 pregnant women with a singleton pregnancy and GDM, randomly assigning them in a 1:1 ratio to one of two glycemic target groups.
- Tight Target Group: Fasting capillary glucose <5.1 mmol/L (<92 mg/dL); 1-hour postprandial glucose <7.0 mmol/L (<126 mg/dL).
- Less Tight Target Group: Fasting capillary glucose <5.3 mmol/L (<95 mg/dL); 1-hour postprandial glucose <7.8 mmol/L (<140 mg/dL).
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Very tight glycemic targets, life-style modification, insulin therapy if needed, Tight-moderate glycemic targets, life-style modification, insulin therapy if needed
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very tight glycemic targets, life-style modification, insulin therapy if neededOther
Also called Tight glycemic targets
All patients are assigned to life-style modification (diet and physical exercise). If target glucose levels (<5.1 mmol/L fasting and <7.0 mmol/L postprandial) are not achieved insulin therapy is started
Tight-moderate glycemic targets, life-style modification, insulin therapy if neededOther
All patients are assigned to life-style modification (diet and physical exercise). If target glucose levels (<5.3 mmol/L fasting and <7.8 mmol/L postprandial) are not achieved insulin therapy is started
| Study group | Role | What they receive |
|---|---|---|
| very tight glycemic targets | Active comparator | Not described Receives: Other: Very tight glycemic targets, life-style modification, insulin therapy if needed |
| tight-moderate glycemic targets | Active comparator | Less tight glycemic targets Receives: Other: Tight-moderate glycemic targets, life-style modification, insulin therapy if needed |
| Control group | No intervention | Only observation in women with normal glucose tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
LGA newborns
Number (%) of large for gestational age (LGA) newborns
Measured: within 24 hours after delivery
TRIB1
Level of expression of TRIB1 gene
Measured: within 24 hours after delivery
LEP
Level of expression of LEP gene
Measured: within 24 hours after delivery
ADIPOQ
Level of expression of ADIPOQ gene
Measured: within 24 hours after delivery
ANGPTL4
Level of expression of ANGPTL4 gene
Measured: within 24 hours after delivery
NR3C1
Level of expression of NR3C1 gene
Measured: within 24 hours after delivery
Secondary outcomes (40)
Cesarian sections
Number (%) of deliveries by Cesarian sections
Measured: within 24 hours after delivery
SGA newborns
Number (%) of small for gestationa age (SGA) newborns
Measured: within 24 hours after delivery
Methylation of candidate genes
Levels of methylation (%) of candidate genes with confirmed differences in the expression in HUVECs isolated within 24 hours after delivery
Measured: within 24 hours after delivery
rate of macrosomia
birth weight ≥4000 g
Measured: delivery
birthweight
birth weight (g)
Measured: delivery
length at birth
length at birth (cm)
Measured: delivery
rate of stillbirth
Foetal death in utero > 20 weeks
Measured: > 20 weeks
rate of neonatal death
death <1 months after delivery
Measured: 1 month after delivery
rate of shoulder dystocia
vaginal cephalic delivery in which, after the head is delivered and gentle traction proves unsuccessful, additional obstetric maneuvers are required to complete the delivery of the fetus
Measured: delivery
rate of birth trauma
bone fracture, damage to nerves
Measured: delivery
rate of preterm birth
babies born at <37 weeks gestational age
Measured: delivery
gestational age
gestational age at delivery
Measured: delivery
rate of neonatal hypoglycemia
plasma glucose level below 2.6 mmol/L within the first 48 hours of age
Measured: first 48 hours of age
rate of neonatal respiratory distress syndrome
respiratory failure or distress
Measured: delivery
rate of jaundice
jaundice necessitating phototherapy and/or exchange transfusion
Measured: delivery
Rate of neonates with Apgar score <7 at 5 minutes
A measure of the health of a newborn infant done at 5 min. The newborn is given points (0, 1, 2) for heart rate, respiratory effort, muscle tone, response to stimulation and skin coloration. A score of 10 points indicates excellent health.
Measured: delivery
rate of NICU admission
neonatal intensive care unit (NICU) admission
Measured: within 72 hours postpartum
length of stay of infants admitted to neonatal intensive care unit
length of stay of infants admitted to neonatal intensive care unit, days
Measured: up to 30 days after delivery
cord blood C-peptide
cord blood C-peptide levels
Measured: delivery
rate of composite neonatal outcome
infant death, shoulder dystocia, bone fracture, and nerve palsy
Measured: delivery
rate of maternal death
death of a woman while pregnant or within 42 days of termination of pregnancy
Measured: within 42 days of termination of pregnancy
rate of eclampsia
generalized convulsions and/or coma
Measured: from 20 weeks to delivery
rate of placental abruption
premature separation of the placenta from the uterine wall before delivery
Measured: before delivery
rate of postpartum hemorrhage
requiring or offered blood transfusion or an operative procedure
Measured: delivery
rate of preeclampsia
onset of new hypertension and proteinuria and/or end-organ dysfunction after 20 weeks of gestation
Measured: from 20 weeks to delivery
rate of gestational hypertension
new-onset hypertension (140/90 mmHg or higher), without proteinuria after 20 weeks of gestation
Measured: from 20 weeks to delivery
rate of induction of labor
the use of medications or other methods to bring on (induce) labour
Measured: delivery
rate of perineal trauma
perineal or deep vaginal laceration
Measured: delivery
rate of operative vaginal delivery (vacuum extraction)
application of vacuum to the foetal head
Measured: delivery
gestational weight gain
Weight from preconception until last weight measured within 4 weeks before delivery.
Measured: delivery
blood pressure at admission to the birth unit
blood pressure at admission to the birth unit, mm Hg
Measured: at admission to the birth unit
rate of maternal hypoglycemia
typical symptoms with capillary glucose <3.9 mmol/L, or, if asymptomatic, by capillary glucose <3.3 mmol/L
Measured: during pregnancy
insulin therapy requirements
Prescription of insulin treatment
Measured: from 12 weeks to delivery
rate of stroke
Maternal sudden loss of brain function due to blocked or burst blood vessels during pregnancy or postpartum.
Measured: during pregnancy or within 42 days after delivery
rate of acute pulmonary oedema
Maternal acute pulmonary oedema
Measured: During pregnancy of within 42 days after delivery
rate of cardiac arrest
Maternal cardiac arrest
Measured: During pregnancy or within 42 days after delivery
rate of maternal respiratory arrest
Measured: During pregnancy or within 42 days after delivery
rate of maternal respiratory distress syndrome
Measured: During pregnancy or within 42 days after delivery
rate of maternal deep vein thrombosis or pulmonary embolus requiring anticoagulant therapy
Measured: During pregnancy or within 42 days after delivery
rate of maternal haemolysis
Measured: During pregnancy or within 42 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study startAug 2015
- Primary completion10 Jun 2022
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women with GDM are randomised to 2 treatment groups: group 1 - treatment group with very tight glycemic targets (\<5.1 mmol / L fasting glucose and \<7.0 mmol / l hour after a meal) and group 2 - treatment group with tight-moderate glycemic targets (\<5.3 mmol / L fasting glucose and \<7.8 mmol / l in an hour after a meal).
- Masking
- None (open label)
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Griniva Elena, MD, PhD, Study director, Almazov NMRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610178
- Sponsor's protocol ID
- 15-14-30012
- Acronym
- GEM GDM
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2017
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hofer OJ, Martis R, Alsweiler J, Crowther CA. Different intensities of glycaemic control for women with gestational diabetes mellitus. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD011624. doi: 10.1002/14651858.CD011624.pub3.
PubMed 37815094
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus: a Randomised Controlled Trial of Different Glycemic Targets During Pregnancy
- ClinicalTrials.gov ID
- NCT03610178
- Acronym / sponsor ID
- GEM GDM / 15-14-30012
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 1 Aug 2018 (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.
This is a randomized controlled trial of different glycemic targets during tratment of women with GDM with assessement of epygenetic aspects of their effects on the fetus and pregnancy outcomes. This study is interventional, randomised controlled trial, open-label.
Detailed description
The study aims to clarify the effect of hyperglycemia and its correction, the level of physical activity and consumption of major macro- and micronutrients by women during pregnancy on DNA methylation and expression of genes involved in neuroendocrine regulation and development of metabolic diseases in offspring, as well as functional characteristics of human umbilical vein endothelial cells (HUVECs). For the purpose of the study women with GDM are randomised to 2 treatment groups per glycemic targets ( very tight and tight-moderate glycemic targets). Data on glycenmic levels during the study and consumption of major macro- and micronutrients will be collected using a mobile application with electronic dairies report forms.
This clinical trial record primarily describes the overarching observational cohort study "Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus" including women with GDM and healthy pregnant women.
Substudy Protocol: A key predefined component of this larger study is an interventional, randomized controlled substudy entitled "Tight versus less tight glycaemic targets for women with gestational diabetes mellitus: a randomised controlled trial" (also known as the GEM GDM Trial).
The GEM GDM Trial is an open-label, randomized controlled trial (RCT) that compares the effects of tight (very tight) versus less tight (tight-moderate) glycemic control on maternal and neonatal outcomes in women diagnosed with Gestational Diabetes Mellitus (GDM). Participants from the main GEM cohort who are diagnosed with GDM according to International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria are eligible for screening and subsequent randomization into this substudy.
The substudy aims to enroll 650 pregnant women with a singleton pregnancy and GDM, randomly assigning them in a 1:1 ratio to one of two glycemic target groups.
- Tight Target Group: Fasting capillary glucose <5.1 mmol/L (<92 mg/dL); 1-hour postprandial glucose <7.0 mmol/L (<126 mg/dL).
- Less Tight Target Group: Fasting capillary glucose <5.3 mmol/L (<95 mg/dL); 1-hour postprandial glucose <7.8 mmol/L (<140 mg/dL).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Women with GDM are randomised to 2 treatment groups: group 1 - treatment group with very tight glycemic targets (<5.1 mmol / L fasting glucose and <7.0 mmol / l hour after a meal) and group 2 - treatment group with tight-moderate glycemic targets (<5.3 mmol / L fasting glucose and <7.8 mmol / l in an hour after a meal).
| Arm | Type | Receives |
|---|---|---|
| very tight glycemic targets | Active comparator | Other: Very tight glycemic targets, life-style modification, insulin therapy if needed |
| tight-moderate glycemic targets | Active comparator | Other: Tight-moderate glycemic targets, life-style modification, insulin therapy if neededLess tight glycemic targets |
| Control group | No intervention | –Only observation in women with normal glucose tolerance |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women with GDM diagnosed according to the Russian national consensus and the recommendations of the International Association of Diabetes and Pregnancy Study Groups (fasting glucose of ≥5.1 mmol/L, and/or ≥10.0 mmol/L after 1 h, and/or ≥8.5 mmol/L after 2 h in oral glucose tolerance test (OGTT) with 75 g of glucose).
- Gestational age at the time of inclusion in the study 12 weeks 0 days - 31 weeks 6 days
- For control group: pregnant women with normal glucose tolerance confirmed by OGTT at 24-31 weeks of gestation.
Key exclusion criteria (4 listed)
- Diabetes mellitus type 1 and tipe 2
- Other deseases that affect methabolism of carbohydrates
- Use of drugs that affect methabolism of carbohydrates
- Malformations of the fetus identifired prior to inclusion to the study.
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 |
|---|---|---|
| Very tight glycemic targets, life-style modification, insulin therapy if neededAlso: Tight glycemic targetsAll patients are assigned to life-style modification (diet and physical exercise). If target glucose levels (<5.1 mmol/L fasting and <7.0 mmol/L postprandial) are not achieved insulin therapy is started | Other | very tight glycemic targets |
| Tight-moderate glycemic targets, life-style modification, insulin therapy if neededAll patients are assigned to life-style modification (diet and physical exercise). If target glucose levels (<5.3 mmol/L fasting and <7.8 mmol/L postprandial) are not achieved insulin therapy is started | Other | tight-moderate glycemic targets |
Primary outcome
LGA newborns
Time frame: within 24 hours after delivery
Number (%) of large for gestational age (LGA) newborns
TRIB1
Time frame: within 24 hours after delivery
Level of expression of TRIB1 gene
LEP
Time frame: within 24 hours after delivery
Level of expression of LEP gene
ADIPOQ
Time frame: within 24 hours after delivery
Level of expression of ADIPOQ gene
ANGPTL4
Time frame: within 24 hours after delivery
Level of expression of ANGPTL4 gene
NR3C1
Time frame: within 24 hours after delivery
Level of expression of NR3C1 gene
40 secondary outcomes
Cesarian sections
Time frame: within 24 hours after delivery
SGA newborns
Time frame: within 24 hours after delivery
Methylation of candidate genes
Time frame: within 24 hours after delivery
rate of macrosomia
Time frame: delivery
birthweight
Time frame: delivery
length at birth
Time frame: delivery
rate of stillbirth
Time frame: > 20 weeks
rate of neonatal death
Time frame: 1 month after delivery
rate of shoulder dystocia
Time frame: delivery
rate of birth trauma
Time frame: delivery
rate of preterm birth
Time frame: delivery
gestational age
Time frame: delivery
rate of neonatal hypoglycemia
Time frame: first 48 hours of age
rate of neonatal respiratory distress syndrome
Time frame: delivery
rate of jaundice
Time frame: delivery
Rate of neonates with Apgar score <7 at 5 minutes
Time frame: delivery
rate of NICU admission
Time frame: within 72 hours postpartum
length of stay of infants admitted to neonatal intensive care unit
Time frame: up to 30 days after delivery
cord blood C-peptide
Time frame: delivery
rate of composite neonatal outcome
Time frame: delivery
rate of maternal death
Time frame: within 42 days of termination of pregnancy
rate of eclampsia
Time frame: from 20 weeks to delivery
rate of placental abruption
Time frame: before delivery
rate of postpartum hemorrhage
Time frame: delivery
rate of preeclampsia
Time frame: from 20 weeks to delivery
rate of gestational hypertension
Time frame: from 20 weeks to delivery
rate of induction of labor
Time frame: delivery
rate of perineal trauma
Time frame: delivery
rate of operative vaginal delivery (vacuum extraction)
Time frame: delivery
gestational weight gain
Time frame: delivery
blood pressure at admission to the birth unit
Time frame: at admission to the birth unit
rate of maternal hypoglycemia
Time frame: during pregnancy
insulin therapy requirements
Time frame: from 12 weeks to delivery
rate of stroke
Time frame: during pregnancy or within 42 days after delivery
rate of acute pulmonary oedema
Time frame: During pregnancy of within 42 days after delivery
rate of cardiac arrest
Time frame: During pregnancy or within 42 days after delivery
rate of maternal respiratory arrest
Time frame: During pregnancy or within 42 days after delivery
rate of maternal respiratory distress syndrome
Time frame: During pregnancy or within 42 days after delivery
rate of maternal deep vein thrombosis or pulmonary embolus requiring anticoagulant therapy
Time frame: During pregnancy or within 42 days after delivery
rate of maternal haemolysis
Time frame: During pregnancy or within 42 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 37815094Hofer OJ, Martis R, Alsweiler J, Crowther CA. Different intensities of glycaemic control for women with gestational diabetes mellitus. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD011624. doi: 10.1002/14651858.CD011624.pub3.
- 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.
Griniva Elena, MD, PhD study director
Almazov NMRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very tight glycemic targets, life-style modification, insulin therapy if needed and Tight-moderate glycemic targets, life-style modification, insulin therapy if needed in people with Gestational Diabetes Mellitus, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LGA newborns (time frame: within 24 hours after delivery). The study lists 6 primary outcomes in all. 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 NCT03610178, which also lists 1 linked publication.
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 21 Nov 2025.