Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 936
Healthy volunteers: no

Brief summary:
The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.

Detailed description:

Arms:
arm 1: Pioglitazone Capsules 15 mg once daily arm 2: Pioglitazone Capsules 30 mg once daily arm 3: Pioglitazone Capsules 45 mg once daily arm 4: Linagliptin 5mg Tablets once daily arm 5: Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily arm 6: Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily arm 7: Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily

Interventions: intervention 1: Pioglitazone 15 mg intervention 2: Pioglitazone 45 mg intervention 3: Pioglitazone 30 mg intervention 4: Linagliptin 5mg / Pioglitazone 45 mg FDC intervention 5: Linagliptin 5mg / Pioglitazone 30 mg FDC intervention 6: Linagliptin 5mg intervention 7: Linagliptin 5mg / Pioglitazone 15 mg FDC
Intervention descriptions: intervention 1: Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks intervention 2: Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks intervention 3: Pioglitazone Capsules 30 mg once daily for up to 84 weeks intervention 4: Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks intervention 5: Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks intervention 6: Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks intervention 7: Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks

Protocol document: