This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
653
100 mg tablet, orally, once daily.
0.6 mg by subcutaneous (pen) injection, once daily, on Days 1-7; up-titrated on Day 8 to 1.2 mg daily. At Week 12, dose may be increased to 1.8 mg once daily for participants who did not meet protocol-specified glycemic goals.
starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12.
metformin tablets at a dose of ≥1500 mg per day
Change From Baseline in Hemoglobin A1c (A1C)
A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent.
Time frame: Baseline and Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline at Week 26 is defined as Week 26 minus Week 0.
Time frame: Baseline and Week 26
Percentage of Participants Reaching A1C Goal of <7.0%
Time frame: Week 26
Percentage of Participants Reaching A1C Goal of <6.5%
Time frame: Week 26
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.