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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)

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
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220326
Enrollment
150
Registered
2006-11-29
Start date
2006-11-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Interventions

Sponsors

Novartis Pharma K.K.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: - Diagnosis of type 2 diabetes - Patients who have completed study CLAF237A1303 - Outpatients Exclusion Criteria: - Patients who prematurely discontinued Study CLAF237A1303 Other protocol-defined inclusion/exclusion criteria may apply

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Primary Adverse events profile after 52 weeks of treatment Secondary Outcomes: 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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026