Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 880
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: patient to receive a tablet containing low dose empagliflozin and linagliptin once daily arm 2: patient to receive a tablet containing low dose empagliflozin once daily arm 3: patient to receive a tablet containing high dose empagliflozin and linagliptin once daily arm 4: patients to receive a tablet containing high dose empagliflozin once daily

Interventions: intervention 1: empagliflozin 10 mg + linagliptin 5 mg intervention 2: empagliflozin 10 mg intervention 3: empagliflozin 25 mg + linagliptin 5 mg intervention 4: empagliflozin 25 mg intervention 5: Placebo
Intervention descriptions: intervention 1: empagliflozin low dose + linagliptin once daily intervention 2: empagliflozin low dose once daily intervention 3: empagliflozin high dose + linagliptin once daily intervention 4: empagliflozin high dose once daily intervention 5: None

Protocol document: