Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 876
Healthy volunteers: no

Brief summary:
Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients

Detailed description:

Arms:
arm 1: patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID arm 2: patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID arm 3: patient to receive a tablet containing metformin 500mg BID arm 4: patient to receive a tablet containing metformin 1000mg BID arm 5: patient to receive a tablet containing linagliptin 5mg once daily

Interventions: intervention 1: linagliptin2.5mg/metformin1000mg intervention 2: linagliptin2.5mg/metformin1000mg intervention 3: linagliptin 5mg intervention 4: Metformin 500mg intervention 5: linagliptin2.5mg/metformin500mg intervention 6: linagliptin2.5mg/metformin500mg intervention 7: linagliptin 5mg intervention 8: Metformin 1000mg
Intervention descriptions: intervention 1: linagliptin2.5mg/metformin1000mg BID intervention 2: linagliptin2.5mg/metformin1000mg BID intervention 3: linagliptin 5mg once daily intervention 4: Metformin 500mg BID intervention 5: linagliptin2.5mg/metformin500mg BID intervention 6: linagliptin2.5mg/metformin500mg BID intervention 7: linagliptin 5mg once daily intervention 8: Metformin 1000mg BID

Protocol document: