Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

Novartis Pharmaceuticals245 enrolled

Overview

This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

245

Conditions

Type 2 Diabetes

Interventions

VildagliptinDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy * Age in the 20 years or over inclusive * HbA1c in the range of ≥ 6.5 to ≤ 10% Exclusion Criteria: * Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * Significant heart diseases * Significant diabetic complications

Locations (24)

Novartis Investigative Site

Hunabashi, Chiba, Japan

Outcomes

Primary Outcomes

Measure AEs, vital signs, laboratory evaluations

Time frame: 52 weeks

Secondary Outcomes

HBA1c

Time frame: 52 weeks

Fasting Plasma Glucose

Time frame: 52 weeks

Fasting Insulin

Time frame: 52 weeks

Fasting C-peptide

Time frame: 52 weeks

HOMA-B

Time frame: 52 weeks

Data from ClinicalTrials.gov

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