Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axcan Pharma; Forest Laboratories

Criteria

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