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Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes

A Multicenter, Open, Long Term Safety Study of 52 Weeks Treatment With Vildagliptin (100 mg qd) In Patients With Type 2 Diabetes (Extension Study of Study CLAF237A1303)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00389415
Enrollment
150
Registered
2006-10-18
Start date
2006-10-31
Completion date
Unknown
Last updated
2008-11-27

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 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.

Interventions

DRUGVildagliptin

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Adverse events profile after 52 weeks of treatment—

Secondary

MeasureTime frame
Change from baseline to endpoint on HbA1c at 52 weeks—
Change from baseline to endpoint on fasting plasma glucose at 52 weeks—
Change from baseline to endpoint in HOMA B at 52 weeks—
Change from baseline to endpoint in HOMA IR at 52 weeks—
Change from baseline to endpoint in body weight at 52 weeks—

Countries

Japan

Outcome results

None listed

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