A Phase 3 interventional study of Acarbose and Prandial insulin in Gestational Diabetes Mellitus in Pregnancy, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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Among 10 studies testing acarbose in Diabetes Mellitus — none open to participants now, none under way, none of them phase 3. Acarbose · Diabetes Mellitus.
Among the 10 studies testing acarbose in Diabetes Mellitus, this one has the largest enrollment, is the only one that started in 2018, is one of 3 in phase 3, and was the 9th registered.
8,291 studies on the registry are indexed under Diabetes Mellitus; 1,075 are open to participants now.
Browse Diabetes Mellitus studies →None of the 10 studies testing acarbose in Diabetes Mellitus is open now. The open studies under Diabetes Mellitus, anywhere →
Acarbose: first FDA approval 1995 (PRECOSE). What it is approved for, and how studies give it, is on its page →
Of the 649 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 341 is above the median of 80 across 6,024 interventional studies indexed under Diabetes Mellitus.
Median enrollment 141 across the 10 interventional studies. Of the 8 that completed or were terminated, 1 (13%) have results posted.
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2 of 10 have an industry lead sponsor. The 9 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
36 studies in Diabetes Mellitus by Assistance Publique - Hôpitaux de Paris: 7 open now, 8 under way, 1 of them phase 3. Of 21 finished, 0 (0%) have results posted.
Among the 36 studies in Diabetes Mellitus by Assistance Publique - Hôpitaux de Paris, this one is the 8th largest by enrollment of the 24 interventional ones that give a count, is the only one that started in 2018, is one of 5 in phase 3, and was the 19th registered.
Assistance Publique - Hôpitaux de Paris’s Diabetes Mellitus studies by the year they started, since 2004.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing acarbose in Diabetes Mellitus, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Assistance Publique - Hôpitaux de Paris’s 36 in Diabetes Mellitus:
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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.
Phase III study. Prospective, multicenter, non-inferiority, randomized, open-labelled and controlled study with two arms.
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.
Basal insulin may be necessary in both arms to control pre-prandial glucose values.
At delivery:
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Acarbose
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.
Drug: Prandial insulin
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.
Also known as: Glucor 50 mg
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.
Also known as: Rapid acting insulin analog
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.
Time frame: At delivery
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.
Time frame: From two weeks after inclusion : 14 and 37 (+6 days) weeks of amenorrhea to delivery
GLUCOSE CONTROL: HbA1c
Centralized measurement
Time frame: 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.
Time frame: At delivery
Neonatal complications : Birth weight and height,
Birth weight ≥ 4000g Birth weight ≥ 4500g
Time frame: At delivery
Neonatal complications : Small for gestational age infant
SGA: birth weight lower than the 10th percentile for a standard French population
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: At delivery
Neonatal complications : Low Apgar score
5-min Apgar score \< 7
Time frame: At delivery
Neonatal complications : Neonatal respiratory distress syndrome
based on the clinical course, chest X-ray finding, blood gas and acid-base values
Time frame: At delivery
Neonatal complications : Intrauterine fetal or neonatal death;
These endpoints will be extracted from the women' charts
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 3 months after delivery
Infant anthropometrics.
These data will be collected from children's health record
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.
* 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
Time frame: within 10 years after the end of the study
Plan to share: No
Ran from Jul 2018 to primary completion in Aug 2023, 61 months.
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This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acarbose
Assistance Publique - Hôpitaux de Paris →