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CompletedNCT00389415Updated Nov 27, 2008

Long Term Safety of Vildagliptin (100mg qd) 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 2008-11-27.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

This 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is open to patients who have completed core study CLAF237A1303.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Type 2 Diabetes
  • Vildagliptin
  • HbA1c
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In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 150 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Novartis is the lead sponsor of 714 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis as Type 2 Diabetes
  • Patients who have completed study CLAF237A1303
  • Outpatients

Exclusion criteria

Exclusion Criteria:

  • Patients who prematurely discontinued Study CLAF237A1303
  • Other protocol-defined inclusion/exclusioncriterial may apply
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants

Interventions

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What researchers measure

Primary outcomes

  1. Adverse events profile after 52 weeks of treatment

Secondary outcomes

  1. Change from baseline to endpoint on HbA1c at 52 weeks

  2. Change from baseline to endpoint on fasting plasma glucose at 52 weeks

  3. Change from baseline to endpoint in HOMA B at 52 weeks

  4. Change from baseline to endpoint in HOMA IR at 52 weeks

  5. Change from baseline to endpoint in body weight at 52 weeks

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 Nov 27, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00389415
Lead sponsor
Novartis
First posted
Oct 18, 2006
Start date
Oct 2006
Last update
Nov 27, 2008

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 Nov 2008. You cannot join it, but the record below documents what was studied.

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