Gestational Diabetes Mellitus in PregnancyPhase 3ACARB-GDMNCT03380546
Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus.
A Phase 3 study testing Acarbose and Prandial insulin in people with Gestational Diabetes Mellitus in Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Caring for women with gestational diabetes mellitus (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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Acarbose and Prandial insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2018to 22 Feb 2024
- Phase
- Phase 3
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years
- Singleton pregnancy
- GDM diagnosed during pregnancy according to IADPSG criteria
- Self-monitoring of blood glucose
- After at least 7 days of dietary and lifestyle measures, unreached post-prandial glucose control
- 14-37 (+ 6 days) amenorrhea weeks at the time of randomization
- Signed informed consent
Who cannot join
- Prandial insulin use before randomization during this pregnancy
- Use of other oral hypoglycemic agents during this pregnancy
- Multiple pregnancy
- Known hepatic insufficiency
- Long time corticosteroid treatment
- Pre-existing diabetes in pregnancy
Show all 12Show fewer
- Overt diabetes diagnosed during pregnancy (IADPSG criteria)
- Lack of Social Insurance
- Insufficient understanding
- Participant in another investigational drug study at inclusion visit
- Contraindications of acarbose
- Fetal malformation diagnosed by previous fetal ultrasound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-inferiority Between Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. ACARB-GDM Study.
Caring for women with gestational diabetes mellitus (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.
Glucosidase inhibitors (acarbose) reduce intestinal absorption of starch and reduce the rate of complex carbohydrate digestion. It mainly lowers postprandial glucose values and is used in type 2 diabetes for a long time. Less than 2% of a dose is absorbed as active drug in adults, with 34% of the metabolites found in the systemic circulation. Doses of up to 9 and 32 times the human dose were not teratogenic in pregnant rats or rabbits. Limited but reassuring data during pregnancy are available. Acarbose was well tolerated (little gestational weight gain, no hypoglycemia) with digestive discomfort in some women, balanced by treatment satisfaction as compared with insulin injections. Our hypothesis is that treatment aiming to control postprandial glucose values with acarbose as compared with prandial insulin injection will be as efficient and safe, but more convenient and less expensive.
Read the detailed description
Phase III study. Prospective, multicenter, non-inferiority, randomized, open-labelled and controlled study with two arms.
- In the 37 participating hospitals: selection of women with GDM who have unmet post prandial glycemic targets between 14 and 37 (+6 days) weeks of amenorrhea after at least 7 days of dietary and lifestyle measures. They may be treated with basal insulin to control pre prandial glucose values.
- Explanation of protocol, with signature of consent in case of acceptation.
- Randomization . Experimental group: The women will receive acarbose with a progressive increase of dose according to post prandial glucose values and digestive tolerance, with a maximal dose of 3 x 100 mg / day. The progressive titration of acarbose reduces gastro-intestinal side effects. Patients who have not reached the glycemic targets at this highest tolerated dose for at least one meal will receive instead prandial insulin therapy for each meal, whereas acarbose will be stopped. Failure to reach post-prandial target will be defined as 3 or more post-prandial glycaemic values ≥ 1.20 g/L for a given meal in a week (3 values out of 7) after the two weeks of dose adjustment.
- Control group: The women will receive prandial insulin according to usual practice (routine care according to French recommendations): before each meal, with dose titration according to post prandial values. Basal insulin may be necessary in both arms to control pre-prandial glucose values. At delivery:
- Maternal blood samples : 14 ml of blood will be collected at the same time as the sample routinely collected just before delivery for irregular agglutinin test measurement, when the women are perfused.
- Cord fluid : 7 ml will be collected at the same as cord fluid pH is routinely measured just after delivery. There will be 5 aliquots to prepare. The aliquots previously labelled and stowed in the specific boxes for the study will be stored locally and will be transported to the "Centre de Ressources Biologiques"(CRB) of the Jean Verdier Hospital.
- Routine monitoring of the women with GDM in both arms, up to delivery. No use of other oral hypoglycemic agents during pregnancy.
- Last consultation three months after delivery.
- Being tested
- Acarbose, Prandial insulin
- Keywords
- Diabetes, Pregnancy, Gestational, Acarbose
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
Also called Glucor 50 mg
Women will receive acarbose at an initial dose of 50 mg once daily in the beginning of the meal for which the postprandial glucose value is the highest, with progressive increase every 2 days or more: adding a pill before another meal, and then increasing dose of acarbose to 100 mg if post-prandial glucose goals are not obtained, with a maximal dose of 3 x 100 mg / day.
Prandial insulinDrug
Also called Rapid acting insulin analog
Women will receive prandial fast-acting insulin according to usual practice (routine care according to French recommendations), i.e. one injection before each meal usually.
| Study group | Role | What they receive |
|---|---|---|
| acarbose | Experimental | The women will receive acarbose with a progressive increase of dose according to post prandial glucose values and digestive tolerance, with a maximal dose of 3 x 100 mg /day Receives: Drug: Acarbose |
| prandial insulin | Active comparator | The women will receive prandial insulin according to usual practice (routine care according to French recommendations): before each meal, with dose titration according to post prandial values. Receives: Drug: Prandial insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint: birth weight ≥ 90th percentile for gestational age (large for gestational age: LGA) and/or neonatal hypoglycemia and/or shoulder dystocia and/or birth injury.
LGA defined as birth weight greater than the 90th percentile for a standard French population
- Neonatal hypoglycemia defined as at least a blood glucose value less than a 2.0 mmol/l during the two first days of life;
- Shoulder dystocia, defined as vaginal cephalic delivery that requires additional obstetric manoeuvres to deliver the fetus after the head has delivered and gentle traction has failed. We will only consider rotational maneuvers such as Rubin II or Woods corkscrew or Jaquemier maneuvers
- Birth injury defined as plexus injury or clavicle fracture.
Measured: At delivery
Secondary outcomes (17)
GLUCOSE CONTROL: 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 two weeks after inclusion : 14 and 37 (+6 days) weeks of amenorrhea to delivery
GLUCOSE CONTROL: HbA1c
Centralized measurement
Measured: At delivery
GLUCOSE CONTROL: Need for and dose/day of basal and prandial insulin in both arms
This information will be retrieved from the glucose meter, and if not available, from the woman's diary.
Measured: At delivery
Neonatal complications : Birth weight and height,
Birth weight ≥ 4000g Birth weight ≥ 4500g
Measured: At delivery
Neonatal complications : Small for gestational age infant
SGA: birth weight lower than the 10th percentile for a standard French population
Measured: At delivery
Maternal complications : Preeclampsia
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/creatininuria >30 in a random urine sample).
Measured: From two weeks after inclusion to delivery
Maternal complications : 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
Measured: From two weeks after inclusion : 14 and 37 (+6 days) weeks of amenorrhea to delivery
Neonatal complications : Preterm delivery
- Late preterm infant (between 32 and 37 completed weeks' gestation)
- Very preterm infant (28-31 completed weeks' gestation)
- Extreme preterm infant (less than 28 completed weeks' gestation)
Measured: At delivery
Neonatal complications : Low Apgar score
5-min Apgar score < 7
Measured: At delivery
Neonatal complications : Neonatal respiratory distress syndrome
based on the clinical course, chest X-ray finding, blood gas and acid-base values
Measured: At delivery
Neonatal complications : Intrauterine fetal or neonatal death;
These endpoints will be extracted from the women' charts
Measured: From two weeks after inclusion to delivery
Acceptance/satisfaction of two strategies : -Quality of life -Satisfaction questionnaires
Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36)
- use of analogic scales
Measured: At delivery
Side effects of drugs : Maternal 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.
- 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: during the 7 months of treatment
Gastro-intestinal side effects
The events occuring during the last 14 days of pregnancy or gastro-intestinal side effects leading to treatment withdrawl
Measured: from two weeks after inclusion : 14 to 36 weeks of gestation to delivery
Results of oral glucose tolerance test and HbA1c measurement
Test will be performed by the women before follow up visit
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
Conservation of serum and plasma; cord fluid. The samples may be used for further analyses ancillary studies and which could be beneficial for GDM care based on evolution in scientific knowledge.
- The blood samples will be collected at the same time as the sample routinely collected just before delivery for irregular agglutinin test measurement.
- Cord fluid will be collected
Measured: within 10 years after the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start4 Jul 2018
- Primary completion12 Aug 2023
- Study completion22 Feb 2024
Why it stopped: difficulty in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
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
- NCT03380546
- Sponsor's protocol ID
- P150942
- Acronym
- ACARB-GDM
- Status last verified
- Jul 2024
- First submitted
- 7 Nov 2017
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rowan JA, Hague WM, Gao W, Battin MR, Moore MP; MiG Trial Investigators. Metformin versus insulin for the treatment of gestational diabetes. N Engl J Med. 2008 May 8;358(19):2003-15. doi: 10.1056/NEJMoa0707193.
PubMed 18463376Langer O, Conway DL, Berkus MD, Xenakis EM, Gonzales O. A comparison of glyburide and insulin in women with gestational diabetes mellitus. N Engl J Med. 2000 Oct 19;343(16):1134-8. doi: 10.1056/NEJM200010193431601.
PubMed 11036118Holt RI, Lambert KD. The use of oral hypoglycaemic agents in pregnancy. Diabet Med. 2014 Mar;31(3):282-91. doi: 10.1111/dme.12376.
PubMed 24528229Zarate A, Ochoa R, Hernandez M, Basurto L. [Effectiveness of acarbose in the control of glucose tolerance worsening in pregnancy]. Ginecol Obstet Mex. 2000 Jan;68:42-5. Spanish.
PubMed 10774102Platt J, O'Brien W. Title Acarbose therapy for gestational diabetes: a retrospective cohort study (abstract). Review AJOG 2003;189:S107
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Between Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. ACARB-GDM Study.
- ClinicalTrials.gov ID
- NCT03380546
- Acronym / sponsor ID
- ACARB-GDM / P150942
- Keywords
- Diabetes, Pregnancy, Gestational, Acarbose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in recruiting
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 12 Aug 2023 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 21 Dec 2017 (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.
Caring for women with gestational diabetes mellitus (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.
Glucosidase inhibitors (acarbose) reduce intestinal absorption of starch and reduce the rate of complex carbohydrate digestion. It mainly lowers postprandial glucose values and is used in type 2 diabetes for a long time. Less than 2% of a dose is absorbed as active drug in adults, with 34% of the metabolites found in the systemic circulation. Doses of up to 9 and 32 times the human dose were not teratogenic in pregnant rats or rabbits. Limited but reassuring data during pregnancy are available. Acarbose was well tolerated (little gestational weight gain, no hypoglycemia) with digestive discomfort in some women, balanced by treatment satisfaction as compared with insulin injections. Our hypothesis is that treatment aiming to control postprandial glucose values with acarbose as compared with prandial insulin injection will be as efficient and safe, but more convenient and less expensive.
Detailed description
Phase III study. Prospective, multicenter, non-inferiority, randomized, open-labelled and controlled study with two arms.
- In the 37 participating hospitals: selection of women with GDM who have unmet post prandial glycemic targets between 14 and 37 (+6 days) weeks of amenorrhea after at least 7 days of dietary and lifestyle measures. They may be treated with basal insulin to control pre prandial glucose values.
- Explanation of protocol, with signature of consent in case of acceptation.
- Randomization . Experimental group: The women will receive acarbose with a progressive increase of dose according to post prandial glucose values and digestive tolerance, with a maximal dose of 3 x 100 mg / day. The progressive titration of acarbose reduces gastro-intestinal side effects. Patients who have not reached the glycemic targets at this highest tolerated dose for at least one meal will receive instead prandial insulin therapy for each meal, whereas acarbose will be stopped. Failure to reach post-prandial target will be defined as 3 or more post-prandial glycaemic values ≥ 1.20 g/L for a given meal in a week (3 values out of 7) after the two weeks of dose adjustment.
- Control group: The women will receive prandial insulin according to usual practice (routine care according to French recommendations): before each meal, with dose titration according to post prandial values. Basal insulin may be necessary in both arms to control pre-prandial glucose values. At delivery:
- Maternal blood samples : 14 ml of blood will be collected at the same time as the sample routinely collected just before delivery for irregular agglutinin test measurement, when the women are perfused.
- Cord fluid : 7 ml will be collected at the same as cord fluid pH is routinely measured just after delivery. There will be 5 aliquots to prepare. The aliquots previously labelled and stowed in the specific boxes for the study will be stored locally and will be transported to the "Centre de Ressources Biologiques"(CRB) of the Jean Verdier Hospital.
- Routine monitoring of the women with GDM in both arms, up to delivery. No use of other oral hypoglycemic agents during pregnancy.
- Last consultation three months after delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acarbose | Experimental | Drug: AcarboseThe women will receive acarbose with a progressive increase of dose according to post prandial glucose values and digestive tolerance, with a maximal dose of 3 x 100 mg /day |
| prandial insulin | Active comparator | Drug: Prandial insulinThe women will receive prandial insulin according to usual practice (routine care according to French recommendations): before each meal, with dose titration according to post prandial values. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Singleton pregnancy
- GDM diagnosed during pregnancy according to IADPSG criteria
- Self-monitoring of blood glucose
- After at least 7 days of dietary and lifestyle measures, unreached post-prandial glucose control
Key exclusion criteria (12 listed)
- Prandial insulin use before randomization during this pregnancy
- Use of other oral hypoglycemic agents during this pregnancy
- Multiple pregnancy
- Known hepatic insufficiency
- Long time corticosteroid treatment
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 |
|---|---|---|
| AcarboseAlso: Glucor 50 mgWomen will receive acarbose at an initial dose of 50 mg once daily in the beginning of the meal for which the postprandial glucose value is the highest, with progressive increase every 2 days or more: adding a pill before another meal, and then increasing dose of acarbose to 100 mg if post-prandial glucose goals are not obtained, with a maximal dose of 3 x 100 mg / day. | Drug | acarbose |
| Prandial insulinAlso: Rapid acting insulin analogWomen will receive prandial fast-acting insulin according to usual practice (routine care according to French recommendations), i.e. one injection before each meal usually. | Drug | prandial insulin |
Primary outcome
Composite endpoint: birth weight ≥ 90th percentile for gestational age (large for gestational age: LGA) and/or neonatal hypoglycemia and/or shoulder dystocia and/or birth injury.
Time frame: At delivery
LGA defined as birth weight greater than the 90th percentile for a standard French population * Neonatal hypoglycemia defined as at least a blood glucose value less than a 2.0 mmol/l during the two first days of life; * Shoulder dystocia, defined as vaginal cephalic delivery that requires additional obstetric manoeuvres to deliver the fetus after the head has delivered and gentle traction has failed. We will only consider rotational maneuvers such as Rubin II or Woods corkscrew or Jaquemier maneuvers * Birth injury defined as plexus injury or clavicle fracture.
17 secondary outcomes
GLUCOSE CONTROL: Capillary glucose levels
Time frame: From two weeks after inclusion : 14 and 37 (+6 days) weeks of amenorrhea to delivery
GLUCOSE CONTROL: HbA1c
Time frame: At delivery
GLUCOSE CONTROL: Need for and dose/day of basal and prandial insulin in both arms
Time frame: At delivery
Neonatal complications : Birth weight and height,
Time frame: At delivery
Neonatal complications : Small for gestational age infant
Time frame: At delivery
Maternal complications : Preeclampsia
Time frame: From two weeks after inclusion to delivery
Maternal complications : Pregnancy-induced hypertension
Time frame: From two weeks after inclusion : 14 and 37 (+6 days) weeks of amenorrhea to delivery
Neonatal complications : Preterm delivery
Time frame: At delivery
Neonatal complications : Low Apgar score
Time frame: At delivery
Neonatal complications : Neonatal respiratory distress syndrome
Time frame: At delivery
Neonatal complications : Intrauterine fetal or neonatal death;
Time frame: From two weeks after inclusion to delivery
Acceptance/satisfaction of two strategies : -Quality of life -Satisfaction questionnaires
Time frame: At delivery
Side effects of drugs : Maternal hypoglycemia
Time frame: during the 7 months of treatment
Gastro-intestinal side effects
Time frame: from two weeks after inclusion : 14 to 36 weeks of gestation to delivery
Results of oral glucose tolerance test and HbA1c measurement
Time frame: 3 months after delivery
Infant anthropometrics.
Time frame: At month 1, month 2 and month 3
Conservation of serum and plasma; cord fluid. The samples may be used for further analyses ancillary studies and which could be beneficial for GDM care based on evolution in scientific knowledge.
Time frame: within 10 years after the end of the study
Results and safety
The study was stopped early (reason given: difficulty in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 18463376Rowan JA, Hague WM, Gao W, Battin MR, Moore MP; MiG Trial Investigators. Metformin versus insulin for the treatment of gestational diabetes. N Engl J Med. 2008 May 8;358(19):2003-15. doi: 10.1056/NEJMoa0707193.
- Background: PubMed 11036118Langer O, Conway DL, Berkus MD, Xenakis EM, Gonzales O. A comparison of glyburide and insulin in women with gestational diabetes mellitus. N Engl J Med. 2000 Oct 19;343(16):1134-8. doi: 10.1056/NEJM200010193431601.
- Background: PubMed 24528229Holt RI, Lambert KD. The use of oral hypoglycaemic agents in pregnancy. Diabet Med. 2014 Mar;31(3):282-91. doi: 10.1111/dme.12376.
- Background: PubMed 10774102Zarate A, Ochoa R, Hernandez M, Basurto L. [Effectiveness of acarbose in the control of glucose tolerance worsening in pregnancy]. Ginecol Obstet Mex. 2000 Jan;68:42-5. Spanish.
- BackgroundPlatt J, O'Brien W. Title Acarbose therapy for gestational diabetes: a retrospective cohort study (abstract). Review AJOG 2003;189:S107
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acarbose and Prandial insulin in people with Gestational Diabetes Mellitus in Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 3 Jul 2024. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: difficulty in recruiting). Results are not available in the source record.
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?
Composite endpoint: birth weight ≥ 90th percentile for gestational age (large for gestational age: LGA) and/or neonatal hypoglycemia and/or shoulder dystocia and/or birth injury. (time frame: At delivery). 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 NCT03380546, which also lists 5 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 3 Jul 2024.