No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
912
subcutaneous injection, 2mg, once weekly
subcutaneous injection, forced titration to 1.8mg, once daily
Change in HbA1c From Baseline to Week 26
Change in HbA1c from baseline to the treatment endpoint at Week 26.
Time frame: Baseline, Week 26
Percentage of Patients Achieving HbA1c <7.0% at Week 26
Percentage of patients achieving HbA1c \<7.0% at treatment endpoint at Week 26.
Time frame: Baseline, Week 26
Change in Fasting Serum Glucose From Baseline to Week 26
Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.
Time frame: Baseline, Week 26
Change in Body Weight From Baseline to Week 26
Change in body weight from baseline to the treatment endpoint at Week 26.
Time frame: Baseline, Week 26
Change in Total Cholesterol From Baseline to Week 26
Change in total cholesterol from baseline to the treatment endpoint at Week 26.
Time frame: Baseline, Week 26
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Change in HDL-C from baseline to the treatment endpoint at Week 26.
Time frame: Baseline, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline.
Time frame: Baseline, Week 26
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Research Site
Buenos Aires, Argentina
Research site
Mendoza, Argentina
Research Site
Rosario, Argentina
Research Site
Box Hill, Australia
Research Site
Geelong, Australia
Research Site
Keswick, Australia
Research Site
Vienna, Austria
Research site
Bonheiden, Belgium
Research Site
Edegem, Belgium
Research Site
Genk, Belgium
...and 98 more locations
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Change in SBP from baseline to the treatment endpoint at Week 26.
Time frame: Baseline, Week 26
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26
Change in DBP from baseline to the treatment endpoint at Week 26.
Time frame: Baseline, Week 26
Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.
Time frame: Baseline to Week 26