Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

Phase 1

Completed

• Conditions: Gastroparesis
• Interventions: Other: Placebo; Drug: Itopride

• Registration Number: NCT00370084
• Lead Sponsor: Forest Laboratories

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.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2006-05
• Study Completion: 2006-07
• Study First Submitted: 2006-08-28
• Study First Submitted QC: 2006-08-29
• Study First Posted: 2006-08-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Itopride	Itopride	-

Primary Outcome Measures

Name	Time	Method
Gastric emptying assessment	weekly

Secondary Outcome Measures

Name	Time	Method
Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution	weekly

Trial Locations

Locations (1)

University of Adelaide, Department of Medicine; 🇦🇺 Adelaide, South Australia, Australia