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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00099918

Enrollment

717

Registered

2004-12-22

Start date

2004-05-31

Completion date

2005-09-30

Last updated

2017-05-17

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 rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been 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

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

Exclusion criteria

* Pregnancy or lactation * 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
Patients with reduction in HbA1c >/= 0.7% after 24 weeks	—
Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c	—
Change from baseline in fasting plasma glucose at 24 weeks	—
Adverse event profile after 24 weeks of treatment	—
Patients with endpoint HbA1c <7% at 24 weeks	—

Countries

Germany, United States

Outcome results

None listed

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