Conditions: Diabetes Mellitus, Type 2 Hyperglycemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1413
Healthy volunteers: no

Brief summary:
This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

Detailed description:

Arms:
arm 1: Empagliflozin low dose once daily arm 2: Empagliflozin high dose once daily arm 3: Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study. arm 4: Empagliflozin low dose split twice daily + metformin 500 mg twice daily arm 5: Empagliflozin low dose split twice daily + metformin 1000 mg twice daily arm 6: Empagliflozin high dose split twice daily + metformin 500 mg twice daily arm 7: Empagliflozin high dose split twice daily + metformin 1000 mg twice daily arm 8: Metformin 500 mg twice daily arm 9: Metformin 1000 mg twice daily

Interventions: intervention 1: Metformin 500 mg bid intervention 2: Metformin 1000 mg bid intervention 3: Empagliflozin low dose qd intervention 4: Empagliflozin high dose qd intervention 5: Empagliflozin low dose bid intervention 6: Metformin 500 mg bid intervention 7: Empagliflozin high dose bid intervention 8: Empagliflozin low dose bid intervention 9: Metformin 1000 mg bid intervention 10: Metformin 500 mg bid intervention 11: Metformin 1000 mg bid intervention 12: Empagliflozin high dose bid intervention 13: Metformin 1000 mg bid intervention 14: Empagliflozin high dose bid
Intervention descriptions: intervention 1: Metformin 500 mg twice daily intervention 2: Metformin 1000 mg twice daily intervention 3: Empagliflozin low dose once daily intervention 4: Empagliflozin high dose once daily intervention 5: Empagliflozin low dose split twice daily intervention 6: Metformin 500 mg twice daily intervention 7: Empagliflozin high dose split twice daily intervention 8: Empagliflozin low dose split twice daily intervention 9: Metformin 1000 mg twice daily intervention 10: Metformin 500 mg twice daily intervention 11: Metformin 1000 mg twice daily intervention 12: Empagliflozin high dose split twice daily intervention 13: Metformin 1000 mg twice daily intervention 14: Empagliflozin high dose split twice daily

Protocol document: