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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
505
subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
subcutaneous injection, twice daily; titration to target blood glucose level
Change in Glcosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline to week 52
Time frame: baseline, week 52
Percentage of Patients Achieving HbA1c <=7%
Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 52 (percentage = \[number of subjects with HbA1c \<=7% at week 52 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%).
Time frame: 52 weeks
Change in Body Weight
Change in body weight from baseline to week 52.
Time frame: baseline, week 52
Change in Fasting Serum Glucose
Change in fasting serum glucose from baseline to week 52
Time frame: baseline, week 52
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Change in 7-point (pre-breakfast, after breakfast, pre-lunch, after lunch, pre-dinner, after dinner, 0300 hours) SMBG profile from baseline to week 52
Time frame: baseline, week 52
Percentage of Patients With Hypoglycemic Events
Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study divided by the total number of patients who particiapted in the 52 week Parent Study
Time frame: 52 weeks
Change in Rate of Hypoglycemic Events
Change in rate of hypoglycemic events per 30 days per patient from baseline to week 52
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Clinical Hospital Osijek
Osijek, Croatia
Klinica bolnica Dubrava
Zagreb, Croatia
Klinicki bolnicki centar Zagreb-Rebro
Zagreb, Croatia
Opca bolnica "Sveti Duh"
Zagreb, Croatia
Internistische Gemeinschaftspraxis
Augsburg, Germany
Dr. Karlheinz Hehemann
Beckum, Germany
Dr. Klaus Busch
Dortmund, Germany
Medical Clinic and Policlinic 3
Giessen, Germany
Diabetologische Schwerpunktpraxis
Hamburg, Germany
IKFE GmbH
Mainz, Germany
...and 59 more locations
Time frame: baseline, week 52