Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01159249

CLAF237A1308

Details and patient eligibility

About

This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.

Enrollment: 245 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy
• Age in the 20 years or over inclusive
• HbA1c in the range of ≥ 6.5 to ≤ 10%

Exclusion criteria

• Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
• Significant heart diseases
• Significant diabetic complications

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

245 participants in 4 patient groups

Open Met add-on vildagliptin

Other group

Treatment:

Drug: Vildagliptin

Open TZD add-on vildagliptin

Other group

Treatment:

Drug: Vildagliptin

Open α-GI add-on vildagliptin

Other group

Treatment:

Drug: Vildagliptin

Glinides add-on vildagliptin

Other group

Treatment:

Drug: Vildagliptin