A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes

As exenatide slows the rate at which materials leave the stomach, it is likely to alter the rate of intestinal absorption of oral drugs when administered within a certain timeframe relative to exenatide. In addition, the residence time within the stomach of other medication may be prolonged and data from this study will help assess the change in residence time in the presence of therapeutic doses of exenatide. This study will also evaluate the relationship between blood levels of exenatide and parameters measuring rate of stomach emptying.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects with at least 1 year history of type 2 diabetes mellitus.
Subjects controlled by oral antidiabetic agents or diet and exercise demonstrated by a screening HbA1c ≥7.0% and ≤10.0%.
Between the body mass index (BMI) of 19 kg/m2 and 40 kg/m2, inclusive.

Exclusion criteria

Within 4 months of the initial dose of study drug, have received a drug that has not received regulatory approval for any indication.
Persons who have previously completed or withdrawn from this study or any other study investigating exenatide.
Subjects who are using drugs that significantly affect gastrointestinal motility (including acarbose, metoclopramide, and macrolide antibiotics).
Subjects who intend to start new concomitant medication during the study, including over-the counter medication, apart from occasional intake of paracetamol or vitamin/mineral supplements. Anti-emetic medication may be permitted at the investigator's discretion, except those that affect gastrointestinal motility.
Subjects who have used insulin for more than 4 weeks within 3 months prior to screening.
Blood donation of more than 500 mL in the last 3 months of screening or any blood donation within the last month.

Treatment and study plan

exenatide and placebo

Drug

Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day. Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day. Period 3 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. A washout of at least 2.5 days will occur between each treatment period.

Other names: Byetta, AC2993, synthetic exendin-4

Primary outcomes

To detect the mean difference in half gastric emptying time for a solid meal between any treatment and placebo

Time frame: up to 12 hours post meal consumption

A dose of exenatide or placebo is given before the morning meal. After eating the test meal, images will be recorded at approximately 5 minute intervals from ingestion of the test meal until 3 hours after the meal, then every 10 minutes until 6 hours after the meal. In cases where significant radioactivity is observed at 6 hours after the meal, additional scintigraphic images may be taken periodically at the discretion of the investigator, until counts approach low values for up to 12 hours after the meal.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

Eli Lilly and Company

Registry information

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Aug 16, 2007
Registry last updated: Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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