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To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 Diabetes

A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Compare the Effects of 12 Weeks Treatment With Vildagliptin 50 mg Bid to Voglibose 0.2 mg Tid in Patients With Type 2 Diabetes

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00368134
Enrollment
370
Registered
2006-08-24
Start date
2006-08-31
Completion date
Unknown
Last updated
2007-06-28

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 is designed to evaluate the efficacy, safety and tolerability of vildagliptin compared to voglibose in patients with type 2 diabetes. Please note this study is not being conducted in the United States.

Interventions

DRUGVildagliptin

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

Inclusion criteria

* Diagnosis as Type 2 Diabetes * Patients who have been placed on dietary therapy/exercise therapy, without achievement of glycemic control * Outpatients

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 Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frame
Change in HbA1c after 12 weeks

Secondary

MeasureTime frame
Change in FPG after 12 weeks
Change in Fasting Lipids after 12 weeks
Change in HOMA-IR after 12 weeks
Change in HOMA-B after 12 weeks
Safety Profile after 12 weeks treatment

Countries

Japan

Outcome results

None listed

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