Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy

Novartis Pharmaceuticals187 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

187

Conditions

Diabetes Mellitus Type 2

Interventions

VildagliptinDRUG

50mg vildagliptin bid

SitagliptinDRUG

100mg sitagliptin po qd

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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…)

Locations (15)

Novartis Investigative Site

Bad Oeynhausen, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Outcomes

Primary Outcomes

demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin

Fasting Plasma Glucose measured on day 14.

Time frame: 14 days

Secondary Outcomes

To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin

Fasting Plasma Glucose on day 14 analyzed descriptively.

Time frame: 14 days

Data from ClinicalTrials.gov

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