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Efficacy of domperidone (a prokinetic agent) on time in range in digestively asymptomatic type I diabetic patients with delayed gastric emptying
EU CTIS ID: 2024-514838-20-00
What this study is testing
Evaluate the impact of prokinetic treatment of gastric emptying versus placebo on glycemic control defined by CGM (Continuous Glucose Monitoring) criteria in type 1 diabetic patients with delayed gastric emptying and digestively asymptomatic and insufficient glycemic control.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female ≥ 18 years and <75 years
- Known type 1 diabetic patients for > 5 years treated with multi-injection insulin regimen or insulin pump with continuous interstitial glucose recording device (CGM) or closed loop
- Type 1 diabetic patients with glycemic target TIR (70-180 mg/dL) < 60% and/or CV > 40% and/or early postprandial hypoglycemia, or at least 3 predictive pump stops in the postprandial period
- Patient with few symptoms of gastroparesis based on GCSI score ≤ 2
- Person who has read and understood the information letter and signed the consent form
- Person affiliated to a social security scheme
You likely can't join if
- Type 2 diabetic patients
- Pregnant, parturient or breast-feeding women, or those without proven effective contraception
- Patients with contraindications to DOMPERIDONE ARROW 10 mg film-coated tablet: o Hypersensitivity to the active substance or to one of the excipients o Pituitary prolactin tumor (prolactinoma) o Underlying heart disease such as congestive heart failure (NYHA stage ≥2), o Kalemia less than 3.7 mmol/L or greater than 5.5 mmol/L, o Magnesemia less than 0.7 mmol/L o Hepatic impairment (TGO, TGP, GGT>2N, TP<70% (unless on anticoagulant)) o Known prolongation of cardiac conduction intervals, notably the QTc interval (QTc greater than 440 ms for men and greater than 460 ms for women) o Use of drugs that prolong the QTc interval (class IA antiarrhythmics (e.g. disopyramide, hydroquinidine, quinidine) and class III antiarrhythmics (e.g. amiodarone, dofetilide, dronedarone, ibutilide, sotalol), certain antipsychotics (e.g. haloperidol, pimozide, sertindole), certain antidepressants (e.g. citalopram, escitalopram), certain antibiotics (e.g. erythromycin, levifloxacin, moxifloxacin, spiramycin), certain antifungals (e.g. pentamidine, fluconazole), certain antimalarial drugs (in particular halofantrine, lumefantrine), certain digestive drugs (e.g. cisapride, dolasetron, prucalopride), certain antihistamines (e.g. mequitazine, mizolastine), certain anticancer drugs (e.g. toremifene, vandetanib, vincamine), certain other drugs (e.g. bepridil, diphemanil, methadone), apomorphine (unless the benefit of concomitant administration outweighs the risks, and only if the precautions recommended for concomitant administration are strictly observed). o Taking levodopa o Use of drugs that are potent or moderate inhibitors of CYP3A4: antiproteases, systemic azole antifungals, certain macrolide antibiotics (clarithromycin, telithromycin, azithromycin, roxithromycin, etc.), diltiazem, verapamil, etc. o Bradycardia (< 50 bpm) o Use of medication that induces bradycardia and hypokalemia o Presence of gastrointestinal bleeding, mechanical obstruction or perforation o Lactose contraindication: galactose intolerance, total lactase deficiency, glucose-galactose malabsorption syndrome o Confirmed or suspected pheochromocytoma due to the risk of severe episodes of hypertension
- Person deprived of liberty by an administrative or judicial decision, or person under court protection, sub-guardianship or guardianship
- patients with severe eating disorders
- Patients receiving GLP-1 analog treatment
See the full eligibility criteria
Who can join
- Male or female ≥ 18 years and <75 years
- Known type 1 diabetic patients for > 5 years treated with multi-injection insulin regimen or insulin pump with continuous interstitial glucose recording device (CGM) or closed loop
- Type 1 diabetic patients with glycemic target TIR (70-180 mg/dL) < 60% and/or CV > 40% and/or early postprandial hypoglycemia, or at least 3 predictive pump stops in the postprandial period
- Patient with few symptoms of gastroparesis based on GCSI score ≤ 2
- Person who has read and understood the information letter and signed the consent form
- Person affiliated to a social security scheme
- A woman of childbearing potential (a woman is considered to be of childbearing potential fertile, after menarche and until she reaches menopause, unless she has reached the menopausal, unless she is definitively sterile) with at least effective contraception (i.e. at least: oral progestin-only hormonal contraception for which ovulation inhibition is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide). for at least 1 month and a negative urine B-HCG pregnancy test at inclusion
- Surgically sterile women (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)
- Menopausal women: The postmenopausal state is defined as the absence of menstrual periods for 12 months without any other medical cause. An elevated follicle-stimulating hormone (FSH) level in the post-menopausal interval can be used to confirm a post-menopausal state in women not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months' amenorrhea, a single FSH measurement is insufficient
What rules you out
- Type 2 diabetic patients
- Pregnant, parturient or breast-feeding women, or those without proven effective contraception
- Patients with contraindications to DOMPERIDONE ARROW 10 mg film-coated tablet: o Hypersensitivity to the active substance or to one of the excipients o Pituitary prolactin tumor (prolactinoma) o Underlying heart disease such as congestive heart failure (NYHA stage ≥2), o Kalemia less than 3.7 mmol/L or greater than 5.5 mmol/L, o Magnesemia less than 0.7 mmol/L o Hepatic impairment (TGO, TGP, GGT>2N, TP<70% (unless on anticoagulant)) o Known prolongation of cardiac conduction intervals, notably the QTc interval (QTc greater than 440 ms for men and greater than 460 ms for women) o Use of drugs that prolong the QTc interval (class IA antiarrhythmics (e.g. disopyramide, hydroquinidine, quinidine) and class III antiarrhythmics (e.g. amiodarone, dofetilide, dronedarone, ibutilide, sotalol), certain antipsychotics (e.g. haloperidol, pimozide, sertindole), certain antidepressants (e.g. citalopram, escitalopram), certain antibiotics (e.g. erythromycin, levifloxacin, moxifloxacin, spiramycin), certain antifungals (e.g. pentamidine, fluconazole), certain antimalarial drugs (in particular halofantrine, lumefantrine), certain digestive drugs (e.g. cisapride, dolasetron, prucalopride), certain antihistamines (e.g. mequitazine, mizolastine), certain anticancer drugs (e.g. toremifene, vandetanib, vincamine), certain other drugs (e.g. bepridil, diphemanil, methadone), apomorphine (unless the benefit of concomitant administration outweighs the risks, and only if the precautions recommended for concomitant administration are strictly observed). o Taking levodopa o Use of drugs that are potent or moderate inhibitors of CYP3A4: antiproteases, systemic azole antifungals, certain macrolide antibiotics (clarithromycin, telithromycin, azithromycin, roxithromycin, etc.), diltiazem, verapamil, etc. o Bradycardia (< 50 bpm) o Use of medication that induces bradycardia and hypokalemia o Presence of gastrointestinal bleeding, mechanical obstruction or perforation o Lactose contraindication: galactose intolerance, total lactase deficiency, glucose-galactose malabsorption syndrome o Confirmed or suspected pheochromocytoma due to the risk of severe episodes of hypertension
- Person deprived of liberty by an administrative or judicial decision, or person under court protection, sub-guardianship or guardianship
- patients with severe eating disorders
- Patients receiving GLP-1 analog treatment
- Person taking part in another trial / having taken part in another therapeutic trial (study involving a drug or medical device) which could interfere with the products or procedures being investigated within a period of 4 weeks prior to inclusion
- Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or from giving informed consent
- history of bariatric surgery
- Patients with CGM<70%
- Type 1 diabetic patients with glycemic target TIR (70-180 mg/dL) < 20%
- Patients with renal insufficiency (GFR<60 ml/min according to CKD-EPI formula), - Patients with contraindications to DOMPERIDONE ARROW 10 mg film-coated tablet: o Hypersensitivity to the active substance or to one of the excipients o Pituitary prolactin tumor (prolactinoma) o Underlying heart disease such as congestive heart failure (NYHA stage ≥2), o Kalemia less than 3.7 mmol/L or greater than 5.5 mmol/L, o Magnesemia less than 0.7 mmol/L o Hepatic impairment (TGO, TGP, GGT>2N, TP<70% (unless on anticoagulant)) o Known prolongation of cardiac conduction intervals, notably the QTc interval (QTc greater than 440 ms for men and greater than 460 ms for women) o Use of drugs that prolong the QTc interval (class IA antiarrhythmics (e.g. disopyramide, hydroquinidine, quinidine) and class III antiarrhythmics (e.g. amiodarone, dofetilide, dronedarone, ibutilide, sotalol), certain antipsychotics (e.g. haloperidol, pimozide, sertindole), certain antidepressants (e.g. citalopram, escitalopram), certain antibiotics (e.g. erythromycin, levifloxacin, moxifloxacin, spiramycin), certain antifungals (e.g. pentamidine, fluconazole), certain antimalarial drugs (in particular halofantrine, lumefantrine), certain digestive drugs (e.g. cisapride, dolasetron, prucalopride), certain antihistamines (e.g. mequitazine, mizolastine), certain anticancer drugs (e.g. toremifene, vandetanib, vincamine), certain other drugs (e.g. bepridil, diphemanil, methadone), apomorphine (unless the benefit of concomitant administration outweighs the risks, and only if the precautions recommended for concomitant administration are strictly observed). o Taking levodopa o Use of drugs that are potent or moderate inhibitors of CYP3A4: antiproteases, systemic azole antifungals, certain macrolide antibiotics (clarithromycin, telithromycin, azithromycin, roxithromycin, etc.), diltiazem, verapamil, etc. o Bradycardia (< 50 bpm) o Use of medication that induces bradycardia and hypokalemia o Presence of gastrointestinal bleeding, mechanical obstruction or digestive perforation o Lactose contraindication: galactose intolerance, total lactase deficiency, glucose-galactose malabsorption syndrome
- Contraindication to gastric emptying test : - allergy to eggs, gluten, milk proteins, etc. - hepatic insufficiency - pulmonary diffusion disorders
- Contraindication to placebo (calcium content): hypercalcemia/hypercalciuria, known calcium lithiasis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.