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

NCT ID: NCT00517283

Last Updated: 2015-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2005-06-30

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sequence 1

Exenatide 5 mcg - Exentatide 10 mcg - Placebo

Group Type: EXPERIMENTAL

exenatide and placebo

Intervention Type: 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.

Sequence 2

Exenatide 10 mcg - Placebo - Exenatide 5 mcg

Group Type: EXPERIMENTAL

Exenatide and placebo

Intervention Type: DRUG

Period 1 = 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 2 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. Period 3 = Subcutaneous injections of exenatide 5mcg 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.

Sequence 3

Placebo - Exenatide 5 mcg - Exenatide 10 mcg

Group Type: EXPERIMENTAL

Exenatide and placebo

Intervention Type: DRUG

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

Interventions

exenatide and placebo

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.

Intervention Type: DRUG

Exenatide and placebo

Period 1 = 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 2 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. Period 3 = Subcutaneous injections of exenatide 5mcg 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.

Intervention Type: DRUG

Exenatide and placebo

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

Intervention Type: DRUG

Other Intervention Names

Byetta; AC2993; synthetic exendin-4; Byetta; AC2993; synthetic exendin-4; Byetta; AC2993; synthetic exendin-4

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Malone, MD

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Research Site

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

H8O-EW-GWAM

Identifier Type: -

Identifier Source: org_study_id