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

Study identifier:H8O-EW-GWAM

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Study drug

exenatide and placebo, Exenatide and placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

25 Years - 75 Years

Date

Study Start Date: 01 Jan 2005

Primary Completion Date: 01 Jun 2005

Study Completion Date: 01 Jun 2005

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

Location

Research Site

Nottingham, United Kingdom

Arms	Assigned Interventions
Experimental: Sequence 1 Exenatide 5 mcg - Exentatide 10 mcg - Placebo	Drug: 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. Other Name: Byetta Other Name: AC2993 Other Name: synthetic exendin-4
Experimental: Sequence 2 Exenatide 10 mcg - Placebo - Exenatide 5 mcg	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. Other Name: Byetta Other Name: AC2993 Other Name: synthetic exendin-4
Experimental: Sequence 3 Placebo - Exenatide 5 mcg - Exenatide 10 mcg	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. Other Name: Byetta Other Name: AC2993 Other Name: synthetic exendin-4

"There is no result for the study"

Documents available

Link to study results on ClinicalStudyResults.org
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center null

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

James Malone

Eli Lilly and Company

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Documents available

Link to study results on ClinicalStudyResults.org

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator