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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 (Gastro-TIR)

NCT06695962 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-02-17

No results posted yet for this study

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

Interventions

DRUG

Domperidone 10mg

30 mg per day for 21 days

DRUG

Placebo

3 per day for 21 days

DIAGNOSTIC_TEST

gastric emptying test

gastric emptying test

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2029-06-01
Completion
2029-07-01

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06695962 on ClinicalTrials.gov