Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

A Multicenter, Open Label, Long-Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01159249

Enrollment

245

Registered

2010-07-09

Start date

2010-06-30

Completion date

2012-01-31

Last updated

2020-12-17

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

Conditions

Type 2 Diabetes

Keywords

Vildagliptin, Type 2 Diabetes, HbA1c, Fasting Plasma Glucose, Long-Term Safety

Brief summary

This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.

Interventions

DRUGVildagliptin

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy * Age in the 20 years or over inclusive * HbA1c in the range of ≥ 6.5 to ≤ 10%

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

Measure	Time frame
Measure AEs, vital signs, laboratory evaluations	52 weeks

Secondary

Measure	Time frame
HBA1c	52 weeks
Fasting Plasma Glucose	52 weeks
Fasting Insulin	52 weeks
Fasting C-peptide	52 weeks
HOMA-B	52 weeks

Countries

Japan

Outcome results

None listed

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