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
No
Study drug
exenatide and placebo, Exenatide and placebo
Sex
All
Actual Enrollment
17
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
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Eli Lilly and Company
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
James Malone
Eli Lilly and Company
