Clinical trial NCT01649297
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2012-10-01; Completion date: 2013-12-01
Enrollment: 983 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

Detailed description:

Arms: arm 1: Patients receive Empagliflozin high dose once daily arm 2: Patients receive Empagliflozin high dose split twice daily arm 3: Patients receive Empagliflozin low dose once daily arm 4: Patients receive Empagliflozin low dose split twice daily arm 5: Patients receive placebo matching Empagliflozin
Interventions: intervention 1: Placebo intervention 2: Placebo intervention 3: Placebo intervention 4: Placebo intervention 5: Placebo intervention 6: empagliflozin (low dose qd) intervention 7: Placebo intervention 8: Placebo intervention 9: Placebo intervention 10: Placebo intervention 11: Placebo intervention 12: Placebo intervention 13: Placebo intervention 14: Placebo intervention 15: Placebo intervention 16: Placebo intervention 17: Empagliflozin (high dose qd) intervention 18: empagliflozin (high dose bid) intervention 19: Placebo intervention 20: empagliflozin (low dose bid)
Intervention descriptions: intervention 1: Patients receive placebo matching empagliflozin (low dose qd) intervention 2: Patients receive placebo matching empagliflozin (low dose bid) intervention 3: Patients receive placebo matching Empagliflozin (high dose qd) intervention 4: Patients receive placebo matching Empagliflozin (high dose qd) intervention 5: Patients receive placebo matching Empagliflozin (high dose qd) intervention 6: Patients receive Empagliflozin low dose once daily intervention 7: Patients receive placebo matching empagliflozin (low dose qd) intervention 8: Patients receive placebo matching empagliflozin (low dose bid) intervention 9: Patients receive placebo matching Empagliflozin (high dose bid) intervention 10: Patients receive placebo matching Empagliflozin (high dose bid) intervention 11: Patients receive placebo matching empagliflozin (low dose qd) intervention 12: Patients receive placebo matching empagliflozin (low dose bid) intervention 13: Patients receive placebo matching Empagliflozin (high dose bid) intervention 14: Patients receive placebo matching empagliflozin (low dose qd) intervention 15: Patients receive placebo matching empagliflozin (low dose bid) intervention 16: Patients receive placebo matching Empagliflozin (high dose bid) intervention 17: Patients receive Empagliflozin high dose once daily intervention 18: Patients receive Empagliflozin high dose split twice daily intervention 19: Patients receive placebo matching Empagliflozin (high dose qd) intervention 20: Patients receive Empagliflozin low dose split twice daily

Protocol documents: