A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: exenatide and placebo (Drug); Exenatide and placebo (Drug); Exenatide and placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company
Summary
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.
Clinical Details
Official title: A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: To detect the mean difference in half gastric emptying time for a solid meal between any treatment and placebo
Eligibility
Minimum age: 25 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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- Persons who have previously completed or withdrawn from this study or any other study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.
Locations and Contacts
Research Site, Nottingham, United Kingdom
Additional Information
Starting date: January 2005
Last updated: February 20, 2015
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