The purpose of this study is to assess safety and efficacy of empagliflozin compared to sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment with metformin and have insufficient glycaemic control. The study will assess non-inferiority of empagliflozin to sitagliptin with regards to HbA1c.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Empagliflozin once daily
Placebo matching empagliflozin
Sitagliptin once daily
The change from baseline in HbA1c after 52 weeks of treatment.
Time frame: Baseline and week 52
The change in bodyweight (kg) from baseline after 52 weeks of treatment
Time frame: Baseline and week 52
The change in Systolic Blood Pressure (SBP) from baseline after 52 weeks of treatment
Time frame: Baseline and week 52
The coefficient of durability of HbA1c response between 24 weeks and 52 weeks of treatment
Time frame: Week 24 and week 52
The change in Diastolic Blood Pressure (DBP) from baseline after 52 weeks of treatment
Time frame: Baseline and week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo matching sitagliptin