NCT00517283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
Last Updated

February 23, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

August 14, 2007

Last Update Submit

February 20, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetesgastric emptyingexenatideByettaAmylinLilly

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 12 hours post meal consumption

Study Arms (3)

Sequence 1

EXPERIMENTAL

Exenatide 5 mcg - Exentatide 10 mcg - Placebo

Drug: exenatide and placebo

Sequence 2

EXPERIMENTAL

Exenatide 10 mcg - Placebo - Exenatide 5 mcg

Drug: Exenatide and placebo

Sequence 3

EXPERIMENTAL

Placebo - Exenatide 5 mcg - Exenatide 10 mcg

Drug: Exenatide and placebo

Interventions

Exenatide and placeboDRUG

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.

Also known as: Byetta, AC2993, synthetic exendin-4
Sequence 1

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • James Malone, MD

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 16, 2007

Study Start

January 1, 2005

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

February 23, 2015

Record last verified: 2015-01

Locations

GB(1)