To assess the efficacy and safety of vildagliptin as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220244

Enrollment

200

Registered

2006-05-22

Start date

2006-05-22

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

investigational material(s) Generic name etc : Vildagliptin INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Ages Eligible for Study: 20 Years and above, Genders Eligible for Study: Both Inclusion Criteria: - Diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea - Patients on diet and exercise who have not reached target blood glucose levels - Outpatients Exclusion Criteria: - Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes - Significant cardiovascular complications as defined by the protocol - Significant diabetic complications as defined by the protocol Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Primary Outcomes: Change from baseline to endpoint on HbA1c at 12 weeks Secondary Outcomes: Change from baseline to endpoint on fasting plasma glucose at 12 weeks; Change from baseline to endpoint in HOMA B at 12 weeks; Change from baseline to endpoint in HOMA IR at 12 weeks; Change from baseline to endpoint on fasting lipids at 12 weeks; Adverse events profile after 12 weeks of treatment	—

Outcome results

None listed

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