This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
377
Research Site
Campinas, Brazil
Research Site
Curitiba, Brazil
Research Site
Fortaleza, Brazil
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12
Time frame: Baseline, Week 12
Change in body weight from Baseline to Week 12, and if measured, at each visit
Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)
Time frame: Baseline, Weeks 4, 8, 12
Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit
Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)
Time frame: Baseline, Weeks 4, 8, 12
Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12
Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
Time frame: Baseline, Weeks 4, 8, 12
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Research Site
Goiânia, Brazil
Research Site
Porto Alegre, Brazil
Research Site
Rio de Janeiro, Brazil
Research Site
Salvador, Brazil
Research Site
São José do Rio Preto, Brazil
Research Site
São Paulo, Brazil
Research Site
Aguascalientes, Aguascalientes, Mexico
...and 5 more locations