CClinicalTrials.gg
CompletedNCT00368134Updated Jun 28, 2007

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

A Phase 3 interventional study of Vildagliptin in Diabetes Mellitus, Type 2, sponsored by Novartis. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2007-06-28.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
370
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Type 2 Diabetes
  • Vildagliptin
  • HbA1c
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 370 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All

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

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/exclusion criteria may apply

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
370 participants

Interventions

  • DrugVildagliptin
06

What researchers measure

Primary outcomes

  1. Change in HbA1c after 12 weeks

Secondary outcomes

  1. Change in FPG after 12 weeks

  2. Change in Fasting Lipids after 12 weeks

  3. Change in HOMA-IR after 12 weeks

  4. Change in HOMA-B after 12 weeks

  5. Safety Profile after 12 weeks treatment

07

Study locations

1 site
  • Novartis Pharmaceuticals
    Tokyo, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00368134
Lead sponsor
Novartis
First posted
Aug 24, 2006
Start date
Aug 2006
Last update
Jun 28, 2007

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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