Efficacy of Domperidone (a Prokinetic Agent) on Time in Range in Digestively Asymptomatic Type I Diabetic Patients With Delayed Gastric Emptying (Gastro-TIR)

NCT06695962 | Not Yet Recruiting Phase 3

• 1 other identifier: 2021/0380/HP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 6

Brief Summary

Patients living with type 1 diabetes (PwT1D) still have trouble controlling their blood sugar, even with the latest treatments. PwT1D may have slow stomach emptying influencing blood glucose level. Treating this is an important goal. A recent study found that 30% of PwT1D had a slower gastric emptying rate, even though they had no other complications and were not experiencing any digestive issues. Slowing of gastric emptying is linked to gastric hypoglycaemia, which is a life-threatening condition that can affect quality of life, and to higher blood sugar level after eating. This can last throughout the night. Prokinetic treatments for the stomach are good for diabetic patients with slow digestion. These treatments help with stomach pain and, to a lesser extent, with hypoglycemia. However, there is no data on the benefits of such treatments in patients with no digestive symptoms, on glycaemic control as defined by continuous glucose monitoring data. In fact, this may be more relevant than HbA1c in patients with alternating hypo- and/or hyperglycaemia. The investigator thinks that a prokinetic agent like domperidone could improve glycaemic control in PwT1D with slow gastric emptying and glycaemic imbalance. This study tests how domperidone affects blood sugar levels in PwT1D. Patients will be administrated domperidone or a placebo for 28 days. The investigator will see how long T1D patients spend within their blood sugar target range over 14 days using a continuous glucose monitor.

Conditions

Type 1 Diabetic

Outcome Measures

Primary Outcomes (1)

• Percentages of time spent within the TIR (Time In Range) glycemic target range (70-180 mg/dL)

  The difference of percentages of time spent within the TIR glycemic target range (70-180 mg/dL) recorded over 14 days under prokinetic treatment (domperidone) or placebo in T1D patients with gastroparesis and inadequate glycemic control

  14 days after domperidone or placebo

Secondary Outcomes (4)

• Variation in glycemic control criteria : HbA1c assay

  14 days after domperidone of placebo

• Variation in glycemic control criteria : Plasma fructosamine assay

  14 days after domperidone of placebo

• Variation in glycemic control criteria : Insulin dose

  14 days after domperidone of placebo

• Safety Outcome : AE and SAE Occurrence

  105 days

Study Arms (2)

Domperidone then placebo

EXPERIMENTAL

Domperidone 10 mg, 3/days during 28 days, - wash-out (21 days) then placebo 3/days during 28 days

Drug: Domperidone 10mg; Drug: Placebo; Diagnostic Test: gastric emptying test

Placebo then Domperidone

EXPERIMENTAL

Placebo 3/days during 28 days - wash-out (21 days) - then Domperidone 10 mg, 3/days during 28 days

Drug: Domperidone 10mg; Drug: Placebo; Diagnostic Test: gastric emptying test

Interventions

Domperidone 10mg DRUG

30 mg per day for 21 days

Domperidone then placebo; Placebo then Domperidone

Placebo DRUG

3 per day for 21 days

Domperidone then placebo; Placebo then Domperidone

gastric emptying test DIAGNOSTIC_TEST

gastric emptying test

Domperidone then placebo; Placebo then Domperidone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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)
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (6)

CHU Amiens

Amiens, France

Location

CHU de CAEN

Caen, France

Location

CH Dieppe

Dieppe, France

Location

Centre Hospitalier Intercommunal Elbeuf, Louviers, Val de Reuil

Elbeuf, France

Location

GH Le Havre

Le Havre, France

Location

CHU de ROUEN

Rouen, France

Location

MeSH Terms

Interventions

Domperidone

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Gaetan PREVOST, Pr

CONTACT

232889061; gaetan.prevost@chu-rouen.fr

Armelle Guidotti

CONTACT

232888265; armelle.guidotti@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)