Drug Interaction of Vildagliptin (LAF237) With Voglibose in Japanese Patients With Type 2 Diabetes

Novartis Pharmaceuticals24 enrolled

Overview

This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Vildagliptin (LAF237)DRUG

VogliboseDRUG

Vildagliptin and VogliboseDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetic patients with inadequately controlled on diet therapy and exercise therapy (HbA1c in the range 6.5 to 10.0% inclusive by NGSP) Exclusion Criteria: * Fasting plasma glucose ≥ 270 mg/dL A history of Type 1 diabetes or secondary forms of diabetes Treatment of anti-diabetic agents including GLP-1 analogues within 8 weeks or insulin within 6 months prior to screening Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis Investigative Site

Tokyo, Japan

Outcomes

Primary Outcomes

Pharmacokinetics of vildagliptin

Time frame: Up to 12 hours post-dose

Secondary Outcomes

Pharmacodynamic parameters (dipeptidyl peptidase IV (DPP-4) activity, glucagon-like peptide-1(GLP-1), glucose, insulin, glucagon)

Time frame: Up to 4 hours or 12 hours post-dose

Data from ClinicalTrials.gov

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