Prospective, randomized, open-label, clinical trial evaluating the effects of vildagliptin on progression of atherosclerotic plaques in type 2 diabetic patients

Prospective, randomized, open-label, clinical trial evaluating the effects of vildagliptin on progression of atherosclerotic plaques in type 2 diabetic patients - Clinical trial evaluating the effects of vildagliptin on progression of atherosclerotic plaques in type 2 diabetic patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011746

Enrollment

176

Registered

2013-09-14

Start date

2013-09-14

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

Treatment for type 2 diabetes with vildagliptin Treatment for type 2 diabetes without vildagliptin and other dipeptidyl peptidase-4 (DPP-4) inhibitors

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Type 2 diabetic patients who should be treated with anti-diabetic agents recommended by Japan Diabetes Society Guidelines 2) Outpatients 3) Subjects who gave written informed consent

Exclusion criteria

Exclusion criteria: 1) Allergy against vildagliptin 2) Type 1 diabetes or secondary diabetes 3) Under administration of DPP-4 inhibitors 4) Patients with diabetic retinopathy who need or underwent light coagulation and vitreous surgery for diabetic retinopathy within 1 year 5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 6) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits 7) End stage renal disease 8) Symptomatic (NYHA III or IV) congestive heart failure 9) Malignancies or other diseases with poor prognosis 10) Pregnant 11) Severe infectious/traumatic diseases 12) Subjects whose doctor in charge do not agree to join the trial

Design outcomes

Primary

Measure	Time frame
(1) Carotid atherosclerosis evaluated by ultrasound (Intima-media thickness; IMT (meanIM/maxIMT) and plaque score) (2) Area and thickness of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI) 12/24 months after randomization	—

Secondary

Measure	Time frame
(1) Flow-mediated vasodilation in forearm (2) ankle/brachial index and cardio ankle vascular index (3) Markers for diabetes (hemoglobin A1c, glycoalbumin, blood glucose) (4) Serum lipids (5) Markers indicating obesity (e.g. adiponectin) (6) Markers indicating inflammation (e.g. high sensitive CRP) (7) Markers indicating oxidative stress (8-OHdG/ MDA-LDL) (8) Markers indicating chronic renal diseases (urine albumin/L-FABP) (9) Blood/urine urate levels (10) body weight/waist circumference (11) blood pressures	—

Measure

Time frame

(1) Flow-mediated vasodilation in forearm (2) ankle/brachial index and cardio ankle vascular index (3) Markers for diabetes (hemoglobin A1c, glycoalbumin, blood glucose) (4) Serum lipids (5) Markers indicating obesity (e.g. adiponectin) (6) Markers indicating inflammation (e.g. high sensitive CRP) (7) Markers indicating oxidative stress (8-OHdG/ MDA-LDL) (8) Markers indicating chronic renal diseases (urine albumin/L-FABP) (9) Blood/urine urate levels (10) body weight/waist circumference (11) blood pressures

—

Countries

Japan

Contacts

Public ContactMakoto Ayaori

National Defense Medical College Department of Internal Medicine

ayaori@ndmc.ac.jp04-2995-1617

Outcome results

None listed

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