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To Compare the Effect with Vildagliptin (50mg qd, 50mg bid or 100mg qd) to Placebo in Patients with Type 2 Diabetes

To Compare the Effect with Vildagliptin (50mg qd, 50mg bid or 100mg qd) to Placebo in Patients with Type 2 Diabetes

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220283
Enrollment
236
Registered
2006-07-27
Start date
2006-07-27
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

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 - Patients who have been placed on diet and exercise therapy without achieving 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 - Significant diabetic complications Other protocol-defined inclusion/exclusion criteria may apply

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Primary Outcomes: Change from baseline on HbA1c at 12 weeks Secondary Outcomes: Change from baseline on fasting plasma glucose at 12 weeks; Change from baseline on HOMA-veta at 12 weeks; Change from baseline on HOMA-R at 12 weeks; Change from baseline in body weight at 12 weeks; Change from baseline on fasting lipids at 12 weeks

Outcome results

None listed

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