AzTrials
AzTrials

Type 1 DiabeticPhase 3Gastro-TIRNCT06695962

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

A Phase 3 study testing Domperidone 10mg and gastric emptying test in people with Type 1 Diabetic, run by University Hospital, Rouen at 6 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 1 Diabetic
What is being tested?
Domperidone 10mg and gastric emptying test
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
6 sitesFrance
Study dates
1 Mar 2026to 1 Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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)
  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gaetan PREVOST, Pr contact

232889061 ext. +33

gaetan.prevost@chu-rouen.fr

Armelle Guidotti contact

232888265 ext. +33

armelle.guidotti@chu-rouen.fr

6 sites in 1 country

France6 sites

  • CHU Amiens

    Amiens

    Rachel DESAILLOUD, Pr, 322455478 ext. +33, desailloud.rachel@chu-amiens.fr

  • CHU de CAEN

    Caen

    Michael JOUBERT, Pr, 231064575 ext. +33, joubert-m@chu-caen.fr

  • CH Dieppe

    Dieppe

    Caroline FOLOPPE, MD, 232147557 ext. +33, cfoloppe@ch-dieppe.fr

  • Centre Hospitalier Intercommunal Elbeuf, Louviers, Val de Reuil

    Elbeuf

    Julie DROUHARD, MD, 2 32 82 65 42 ext. +33, julie.drouhard@chi-elbeuf-louviers.fr

  • GH Le Havre

    Le Havre

    Clémence BURES, MD, 2 32 73 31 09 ext. +33, clemence.bures@ch-havre.fr

  • CHU de ROUEN

    Rouen

    Gaetan Prevost, Pr, 2 32 88 90 61 ext. +33, gaetan.prevost@chu-rouen.fr

Other trials in France

About this study

Official title: Efficacy of Domperidone (a Prokinetic Agent) on Time in Range in Digestively Asymptomatic Type I Diabetic Patients With Delayed Gastric Emptying

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
Being tested
Domperidone 10mg, Placebo, gastric emptying test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Domperidone 10mgDrug

    30 mg per day for 21 days

  • PlaceboDrug

    3 per day for 21 days

  • gastric emptying testDiagnostic test

    gastric emptying test

Study groups in NCT06695962
Study groupRoleWhat they receive
Domperidone then placeboExperimentalDomperidone 10 mg, 3/days during 28 days, - wash-out (21 days) then placebo 3/days during 28 days
Receives: Drug: Domperidone 10mg; Drug: Placebo; Diagnostic Test: gastric emptying test
Placebo then DomperidoneExperimentalPlacebo 3/days during 28 days - wash-out (21 days) - then Domperidone 10 mg, 3/days during 28 days
Receives: Drug: Domperidone 10mg; Drug: Placebo; Diagnostic Test: gastric emptying test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 14 days after domperidone or placebo

Secondary outcomes (4)

  1. Variation in glycemic control criteria : HbA1c assay

    Variation in HbA1c assay between domperidone and placebo (measurement of differences)

    Measured: 14 days after domperidone of placebo

  2. Variation in glycemic control criteria : Plasma fructosamine assay

    Variation in Plasma fructosamine assay between domperidone and placebo (measurement of differences)

    Measured: 14 days after domperidone of placebo

  3. Variation in glycemic control criteria : Insulin dose

    Variation in Insulin dose between domperidone and placebo (measurement of differences)

    Measured: 14 days after domperidone of placebo

  4. Safety Outcome : AE and SAE Occurrence

    Number of AE and SAE

    Measured: 105 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Jun 2029 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06695962
Sponsor's protocol ID
2021/0380/HP
Acronym
Gastro-TIR
Status last verified
Feb 2026
First submitted
15 Nov 2024
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Domperidone 10mg and gastric emptying test in people with Type 1 Diabetic, run by University Hospital, Rouen at 6 sites 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 9 inclusion and 26 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gaetan PREVOST, Pr (232889061 ext. +33, gaetan.prevost@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentages of time spent within the TIR (Time In Range) glycemic target range (70-180 mg/dL) (time frame: 14 days after domperidone or placebo). 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 NCT06695962.

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 17 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in