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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00099905

Enrollment

639

Registered

2004-12-22

Start date

2004-04-30

Completion date

2005-10-31

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

Brief summary

The purpose of this study is to assess the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Interventions

DRUGvildagliptin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Body mass index (BMI) in the range 22-45 * Blood glucose criteria must be met * Not currently on drug therapy for type 2 diabetes

Exclusion criteria

* Type 1 diabetes * Evidence of serious diabetic complications * Evidence of serious cardiovascular conditions * Laboratory value abnormalities as defined by the protocol * Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1c at 24 weeks	—

Secondary

Measure	Time frame
Change from baseline in fasting plasma glucose at 24 weeks	—
Patients with endpoint HbA1c <7% after 24 weeks	—
Patients with reduction in HbA1c>/=to 0.7% after 24 weeks	—
Change from baseline in body weight at 24 weeks	—
Change from baseline in fasting lipids at 24 weeks	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026