Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00099866

Enrollment

570

Registered

2004-12-22

Start date

2004-01-31

Completion date

2005-08-31

Last updated

2012-05-07

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 vildagliptin, an unapproved drug, compared to metformin 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

DRUGMetformin Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Type 1 diabetes * Pregnancy or lactation * 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 52 weeks	—

Secondary

Measure	Time frame
Change from baseline in fasting plasma glucose at 52 weeks	—
Adverse event profile after 52 weeks of treatment	—
Change from baseline in body weight at 52 weeks	—
Change from baseline in fasting lipids at 52 weeks	—
Change from baseline in HOMA B at 52 weeks	—

Countries

Germany

Outcome results

None listed

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