Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy (FPG-VISIT)

Novartis

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Sitagliptin; Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01398592

CLMF237ADE02

2011-000518-21 (EudraCT Number)

Details and patient eligibility

About

This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG) lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.

Enrollment: 187 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with type 2 diabetes 18 to 85 years Metformin monotherapy > 4 weeks HbA1c 6.5 - 9.5%

Exclusion criteria

FPG > 270 mg/dl Use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (MI, stroke...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

187 participants in 2 patient groups

Vildagliptin

Experimental group

Description:

Experimental

Treatment:

Drug: Vildagliptin

Sitagliptin

Active Comparator group

Description:

Active comparator (drug)

Treatment:

Drug: Sitagliptin