Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia
NCT ID: NCT00370084
Last Updated: 2017-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2005-03-31
2006-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
oral, three times daily
Itopride
Itopride
oral, three times daily
Interventions
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Itopride
oral, three times daily
Placebo
oral, three times daily
Eligibility Criteria
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Inclusion Criteria
* 18 to 65 years old
* Glycated haemoglobin level (HbA1c) below 9%
* Body mass index (BMI) between 18 and 35 kg/m2
Exclusion Criteria
* Exposure to radiation for research purposes during the previous 12 months
18 Years
65 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Horowitz, M.D.
Role: PRINCIPAL_INVESTIGATOR
Royal Adelaide Hospital
Locations
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University of Adelaide, Department of Medicine
Adelaide, South Australia, Australia
Countries
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Other Identifiers
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041026
Identifier Type: -
Identifier Source: secondary_id
ITODG04-01
Identifier Type: -
Identifier Source: org_study_id
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