Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: Vildagliptin AM; Drug: vildagliptin pm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00351884

CLAF237A23103

Details and patient eligibility

About

Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.

Enrollment: 370 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
• Body mass index in the range 22-40
• Blood glucose criteria must be met

Exclusion criteria

• Pregnancy or lactation
• History of type 1 diabetes
• Evidence of significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

370 participants in 3 patient groups, including a placebo group

vildagliptin am

Experimental group

Treatment:

Drug: Vildagliptin AM

vildagliptin pm

Experimental group

Treatment:

Drug: vildagliptin pm

placebo

Placebo Comparator group

Treatment:

Drug: placebo