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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
exenatide and placebo
Exenatide and placebo
Exenatide and placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, gastric emptying, exenatide, Byetta, Amylin, Lilly

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Persons who have previously completed or withdrawn from this study or any other study investigating exenatide.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.

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Arm Description

Exenatide 5 mcg - Exentatide 10 mcg - Placebo

Exenatide 10 mcg - Placebo - Exenatide 5 mcg

Placebo - Exenatide 5 mcg - Exenatide 10 mcg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 14, 2007
Last Updated
February 20, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00517283
Brief Title
A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes
Official Title
A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, gastric emptying, exenatide, Byetta, Amylin, Lilly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Exenatide 5 mcg - Exentatide 10 mcg - Placebo
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Exenatide 10 mcg - Placebo - Exenatide 5 mcg
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Placebo - Exenatide 5 mcg - Exenatide 10 mcg
Intervention Type
Drug
Intervention Name(s)
exenatide and placebo
Other Intervention Name(s)
Byetta, AC2993, synthetic exendin-4
Intervention Description
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
Intervention Name(s)
Exenatide and placebo
Other Intervention Name(s)
Byetta, AC2993, synthetic exendin-4
Intervention Description
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
Intervention Name(s)
Exenatide and placebo
Other Intervention Name(s)
Byetta, AC2993, synthetic exendin-4
Intervention Description
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.
Primary Outcome Measure Information:
Title
To detect the mean difference in half gastric emptying time for a solid meal between any treatment and placebo
Description
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.
Time Frame
up to 12 hours post meal consumption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Malone, MD
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Nottingham
Country
United Kingdom

12. IPD Sharing Statement

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

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