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Open, Long-Term Safety Study With Vildagliptin in Patients With Type 2 Diabetes (as add-on therapy with metformin, thiazolidinedione, alpha-glucosidase inhibitor or rapid-acting insulin secretagogues)

Open, Long-Term Safety Study With Vildagliptin in Patients With Type 2 Diabetes (as add-on therapy with metformin, thiazolidinedione, alpha-glucosidase inhibitor or rapid-acting insulin secretagogues)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221153
Enrollment
216
Registered
2010-07-08
Start date
2010-07-08
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 : LAF237 INN of investigational material : Vildagliptin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational m

Sponsors

Novartis Pharma K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or alpha-GI, or glinides monotherapy - Age in the 20 years or over inclusive - HbA1c in the range of >= 6.5 to =< 10%

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

Design outcomes

Primary

MeasureTime frame
Safety—

Secondary

MeasureTime frame
HbA1c, fasting plasma glucose, fasting insulin, fasting c-peptide, HOMA-B—

Outcome results

None listed

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