Study for the effects of vildagriptin in combination with metformin on vascular endothelial function and systemic metabolism in patients with type 2 diabetes -multicenter, prospective, randomized, open-label, parallel group comparison-

Study for the effects of vildagriptin in combination with metformin on vascular endothelial function and systemic metabolism in patients with type 2 diabetes -multicenter, prospective, randomized, open-label, parallel group comparison- - Study for the effects of vildagriptin in combination with metformin on vascular endothelial function and systemic metabolism in type 2 DM patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011063

Enrollment

110

Registered

2013-06-28

Start date

2013-07-01

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 mellitus

Interventions

vildagliptin metformin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Outpatients with type 2 diabetes who meet following criteria: 1) age: 20 - 75 years old, 2) HbA1c: 7.0-8.5%, 3) administrating 500-750mg of metformin more than 4 weeks, 4) well-controlled in terms of blood pressure and lipids, 5) made a written informed consent

Exclusion criteria

Exclusion criteria: 1) patients who receive insulin injection therapy, 2) severe respiratory disease, renal dysfunction and heart disease, 3) moderate or severe renal dysfunction (1.3 and 1.2 mg/dL or more for male and female, respectively), 4) hepatitis or hepatocirrhosis (AST/GOT or ALT/GPT: 100U or more), 5) malignant tumor, 6) history of angina, myocardial infarction, stroke or arteriosclerotic diseases, 7) patients who receive thiazolidinediones, alpha-glucosidase inhibitor, GLP-1 receptor agonist or DPP-4 inhibitor in 8 weeks, 8) hypersensitivity to study drugs on this study, 9) pregnancy, nursing woman or possibly pregnant woman, 10) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Design outcomes

Primary

Measure	Time frame
Change in FMD (Flow Mediated Dilatation) between the treatment groups	—

Secondary

Measure	Time frame
1) Change in Endo-PAT between the treatment groups, 2) change in FMD within each group, 3) correlation between FMD and HbA1c, 4) change between the treatment groups and within each groups in blood sugar tests such as HbA1c, FPG 1,5AG and GA, beta cell function, TBI (Toe-brachial index) , Task force monitor, laboratory tests and biomarkers, 4) safety	—

Countries

Japan

Contacts

Public ContactHideaki Miyoshi

Graduate School of Medicine, Hokkaido University Department of Internal Medicine II

hmiyoshi@med.hokudai.ac.jp011-706-5915

Outcome results

None listed

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