Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

Effects of Itopride Hydrochloride on Gastric Emptying, Glycaemia and Meal-related Symptoms in Patients With Type 1 and Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00370084

Enrollment

Registered

2006-08-30

Start date

2005-03-31

Completion date

2006-07-31

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroparesis

Brief summary

Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis. Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. The goal of this study is to evaluate the effects of Itopride on gastric motor function and glycemia in patients with diabetes.

Detailed description

This is a mechanistic study evaluating in a cross-over design the effects of Itopride hydrochloride. The primary objective of this study is to evaluate the acute effects of itopride hydrochloride (200 mg three times daily) on gastric emptying of solid and liquid meal components in patients with type 1 and type 2 diabetes mellitus. Secondary objectives are to evaluate the effects of itopride hydrochloride on the glycaemic response to a meal, meal-related upper gastrointestinal symptoms and intragastric meal distribution.

Interventions

DRUGItopride

oral, three times daily

OTHERPlacebo

oral, three times daily

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Type-1 and Type-2 diabetic patients * 18 to 65 years old * Glycated haemoglobin level (HbA1c) below 9% * Body mass index (BMI) between 18 and 35 kg/m2

Exclusion criteria

* Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g. prokinetic drugs, macrolide antibiotics) * Exposure to radiation for research purposes during the previous 12 months

Design outcomes

Primary

Measure	Time frame
Gastric emptying assessment	weekly

Secondary

Measure	Time frame
Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution	weekly

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026