Study Examining Exenatide Long-Acting Release in Subjects with Type 2 Diabetes
Study identifier:2993LAR-104
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Safety and Pharmacokinetics of Exenatide Long-Acting Release Administered Weekly in Subjects with Type 2 Diabetes Mellitus
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 2
Healthy volunteers
No
Study drug
placebo, Exenatide LAR
Sex
All
Actual Enrollment
45
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Feb 2005
Primary Completion Date: 01 Oct 2005
Study Completion Date: 01 Oct 2005
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double 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 |
|---|---|
| Placebo Comparator: Group A1 Placebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR | Drug: placebo Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg |
| Placebo Comparator: Group A2 Placebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR | Drug: placebo Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg |
| Experimental: Group B Exenatide lead-in followed by exenatide LAR 0.8 mg weekly | Drug: Exenatide LAR Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg. Other Name: Bydureon |
| Experimental: Group C Exenatide lead-in followed by exenatide LAR 2.0 mg weekly | Drug: Exenatide LAR Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg. Other Name: Bydureon |
Contacts
Investigators
Principal Investigator
Lisa Porter
Amylin Pharmaceuticals
