Study identifier:2993LAR-104
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Type 2 Diabetes Mellitus
Phase 2
No
placebo, Exenatide LAR
All
45
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Eli Lilly and Company
Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.
Location
Location
San Antonio, TX, United States
Location
Butte, MT, United States
Location
Walnut Creek, CA, United States
Location
St. Louis, MO, United States
Location
Honolulu, HI, United States
Location
Olympia, WA, United States
Location
Portland, OR, United States
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 |
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