Study identifier:H8O-MC-GWAD
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Efficacy of Exenatide (AC2993, Synthetic Exendin-4, LY2148568) Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin
Diabetes Mellitus, Type 2
Phase 3
No
exenatide, biphasic insulin aspart
All
505
Interventional
30 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Eli Lilly and Company
This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
Location
Location
Zagreb, Croatia, 10000
Location
Zagreb, Croatia, 10000
Location
Osijek, Croatia, 31000
Location
Zagreb, Croatia, 10000
Location
Neuwied, Germany, 56564
Location
Dortmund, Germany, 44137
Location
Augsburg, Germany, 86150
Location
Oschatz, Germany, 04758
Arms | Assigned Interventions |
---|---|
Experimental: Exenatide Arm subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks | Drug: exenatide subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks Other Name: Byetta |
Active Comparator: Biphasic Insulin Aspart Arm subcutaneous injection, twice daily; titration to target blood glucose level | Drug: biphasic insulin aspart subcutaneous injection, twice daily; titration to target blood glucose level Other Name: NovoLog |
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