The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
255
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day
Research Site
Buenos Aires, Argentina
Change in HbA1c (Percent)
Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values \[X% - Y%\]
Time frame: Baseline to 20 Weeks
Percentage of Patients Achieving HbA1c <=7.0%
Percentage of patients whose baseline HbA1c was \> 7.0% achieving HbA1c \<=7.0% at endpoint (Week 20)
Time frame: Baseline to 20 Weeks
Percentage of Patients Achieving HbA1c <7.0%
Percentage of patients whose baseline HbA1c was \>=7.0% achieving HbA1c \<7.0% at endpoint (Week 20)
Time frame: Baseline to 20 Weeks
Percentage of Patients Achieving HbA1c <=6.5%
Percentage of patients whose baseline HbA1c was \> 6.5% achieving HbA1c \<=6.5% at endpoint (Week 20)
Time frame: Baseline to 20 Weeks
Change in FSG (mmol/L)
Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)
Time frame: Baseline to 20 Weeks
Change in Body Weight (kg)
Change in body weight from baseline to endpoint (Week 20)
Time frame: Baseline to 20 Weeks
Change in Waist Circumference (cm)
Change in waist circumference from baseline to endpoint (Week 20)
Time frame: Baseline to 20 Weeks
Waist-to-Hip Ratio
Change in waist-to-hip ratio from baseline to endpoint (Week20)
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Research Site
Morón, Argentina
Research Site
Adelaide, Australia
Research Site
Geelong, Australia
Research Site
Melbourne, Australia
Research Site
Aschaffenburg, Germany
Research Site
Aßlar, Germany
Research Site
Beckum-Neubeckum, Germany
Research Site
Berlin, Germany
Research Site
Bosenheim, Germany
...and 26 more locations
Time frame: Baseline to 20 Weeks
SMBG (mmol/L)
7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)
Time frame: Baseline to 20 Weeks
Change in Triglycerides (mmol/L)
Change in triglycerides from baseline to endpoint (Week 20)
Time frame: Baseline to 20 Weeks
Change in HDL (mmol/L)
Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)
Time frame: Baseline to 20 Weeks
Change in LDL (mmol/L)
Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)
Time frame: Baseline to 20 Weeks
Change in Total Cholesterol (mmol/L)
Change in total cholesterol from baseline to endpoint (Week 20)
Time frame: Baseline to 20 Weeks
Incidence of Hypoglycemia (Overall)
Incidence of hypoglycemic episodes experienced overall during the study
Time frame: Baseline to 20 Weeks
Incidence of Severe Hypoglycemia(Overall)
Incidence of severe hypoglycemia experienced overall during the study
Time frame: Baseline to 20 Weeks
Incidence of Nocturnal Hypoglycemia (Overall)
Incidence of nocturnal hypoglycemia experienced overall during the study
Time frame: Baseline to 20 Weeks
Incidence of Confirmed Hypoglycemia(Overall)
Incidence of confirmed hypoglycemia experienced overall during the study
Time frame: Baseline to 20 Weeks