Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus

Novartis

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01224366

CLAF237A23135

Details and patient eligibility

About

To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.

Enrollment: 448 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of T2DM
• On a stable dose of insulin as defined by the protocol
• On a stable does of metformin (if applicable) as defined by the protocol
• Age 18 to 80 years
• HbA1c of 7.5 to 11.0%
• Body Mass Index (BMI) 22 to 40 kg/m2

Exclusion criteria

• Type 1 diabetes
• Short-acting or rapid-acting insulin
• Pregnancy or lactation
• Evidence of serious diabetic complications
• Evidence of serious cardiovascular complications
• Laboratory value abnormalities as defined by the protocol
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

448 participants in 2 patient groups, including a placebo group

Vildagliptin

Experimental group

Treatment:

Drug: Vildagliptin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo