A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00238498

Enrollment

291

Registered

2005-10-13

Start date

2004-07-31

Completion date

2005-06-30

Last updated

2012-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes, vildagliptin, HbA1c

Brief summary

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.

Interventions

DRUGvildagliptin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Inclusion criteria

* Diagnosis of type 2 diabetes * Patients who have been placed on diet and exercise therapy without achievement of glycemic control * Outpatients

Exclusion criteria

* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * Significant cardiovascular diseases * Significant diabetic complications * Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1c at 12 weeks	—

Secondary

Measure	Time frame
Change from baseline for postprandial glucose at 12 weeks	—
Change from baseline on fasting plasma glucose at 12 weeks	—
Change from baseline on postprandial glucose AUC at 12 weeks	—
Change from baseline in HOMA B at 12 weeks	—
Change from baseline in HOMA IR at 12 weeks	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026