Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus
Status:
Completed
Trial end date:
2017-06-16
Target enrollment:
Participant gender:
Summary
Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will
evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg +
linagliptin. All analyses will be carried out separately for these study parts. The objective
of Part A is to investigate the efficacy, safety and tolerability of the fixed dose
combination (FDC) of empagliflozin 10 mg / linagliptin 5 mg compared with empagliflozin 10 mg
plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients
with T2DM (Type 2 Diabetes Mellitus) who have insufficient glycaemic control after 16 weeks
of treatment with empagliflozin 10 mg alone once daily. The study is designed to show
superiority of the FDC of empagliflozin 10 mg / linagliptin 5 mg over empagliflozin 10 mg
plus FDC matching placebo after 24 weeks of treatment. The objective of Part B is to
investigate the efficacy, safety and tolerability of the FDC of empagliflozin 25 mg /
linagliptin 5 mg compared with empagliflozin 25 mg plus FDC matching placebo administered
orally once daily for 24 weeks in Japanese patients with T2DM who have insufficient glycaemic
control after 16 weeks of treatment with empagliflozin 25 mg alone once daily. The study is
designed to show superiority of the FDC of empagliflozin 25 mg / linagliptin 5 mg over
empagliflozin 25 mg plus FDC matching placebo after 24 weeks of treatment. The 24 week
treatment period will be followed by a 28 week extension treatment period to evaluate further
efficacy and safety up to 52 weeks.