Stomach drug may tame blood sugar swings in type 1 diabetes
NCT ID NCT06695962
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether domperidone, a drug that speeds up stomach emptying, can help people with type 1 diabetes keep their blood sugar in a healthy range. About 70 adults with type 1 diabetes who have slow stomach emptying but no digestive symptoms will take either domperidone or a placebo for 28 days. The main goal is to see if the drug increases the time their blood sugar stays within the target range, measured by a continuous glucose monitor.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) * Type 1 diabetic patients with glycemic target TIR (70-180 mg/dL) \< 60% and/or CV \> 40% and/or early postprandial hypoglycemia * 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-menopausalinterval 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 Exclusion Criteria: * Type 2 diabetic patients * Patients with CGM\<70% * Type 1 diabetic patients with glycemic target TIR (70-180 mg/dL) \< 40% * Patients with renal insufficiency (GFR\<60 ml/min according to CKD-EPI formula), * Patients with contraindications to DOMPERIDONE ARROW 10 mg film-coated tablet: * Hypersensitivity to the active substance or to one of the excipients * Pituitary prolactin tumor (prolactinoma) * Underlying heart disease such as congestive heart failure (NYHA stage ≥2), * Kalemia less than 3.7 mmol/L or greater than 5.5 mmol/L, * Magnesemia less than 0.7 mmol/L * Hepatic impairment (TGO, TGP, GGT\>2N, TP\<70% (unless on anticoagulant)) * Known prolongation of cardiac conduction intervals, notably the QTc interval (QTc greater than 440 ms for men and greater than 460 ms for women) * 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). * Taking levodopa * 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. * Bradycardia (\< 50 bpm) * Use ofmedication that induces bradycardia and hypokalemia * Presence of gastrointestinal bleeding, mechanicalobstruction or digestive perforation * 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 * Pregnant, parturient or breast-feeding women, or those without proven effective contraception * Person deprived of liberty by an administrative or judicial decision, or person under court protection, subguardianship or guardianship * 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 * Patients treated with a closed insulin loop
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CH Dieppe
Dieppe, France
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CHU Amiens
Amiens, France
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CHU de CAEN
Caen, France
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CHU de ROUEN
Rouen, France
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Centre Hospitalier Intercommunal Elbeuf, Louviers, Val de Reuil
Elbeuf, France
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GH Le Havre
Le Havre, France
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Other studies related to the condition(s) this trial covers.
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