UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011746 |
|---|---|
| Receipt number | R000013735 |
| Scientific Title | Prospective, randomized, open-label, clinical trial evaluating the effects of vildagliptin on progression of atherosclerotic plaques in type 2 diabetic patients |
| Date of disclosure of the study information | 2013/09/14 |
| Last modified on | 2018/05/24 14:21:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective, randomized, open-label, clinical trial evaluating the effects of vildagliptin on progression of atherosclerotic plaques in type 2 diabetic patients
Acronym
Clinical trial evaluating the effects of vildagliptin on progression of atherosclerotic plaques in type 2 diabetic patients
Scientific Title
Prospective, randomized, open-label, clinical trial evaluating the effects of vildagliptin on progression of atherosclerotic plaques in type 2 diabetic patients
Scientific Title:Acronym
Clinical trial evaluating the effects of vildagliptin on progression of atherosclerotic plaques in type 2 diabetic patients
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare therapies with or without vildagliptin on carotid/aortic atherosclerotic plaques in type 2 diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(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
Key secondary outcomes
(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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment for type 2 diabetes with vildagliptin
Interventions/Control_2
Treatment for type 2 diabetes without vildagliptin and other dipeptidyl peptidase-4 (DPP-4) inhibitors
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key 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
Key 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
Target sample size
176
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsunori Ikewaki |
Organization
National Defense Medical College
Division name
Department of Internal Medicine
Zip code
Address
3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL
04-2995-1617
katsunorike@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ayaori |
Organization
National Defense Medical College
Division name
Department of Internal Medicine
Zip code
Address
3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL
04-2995-1617
Homepage URL
ayaori@ndmc.ac.jp
Sponsor or person
Institute
Makoto Ayaori
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2013 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 13 | Day |
Last modified on
| 2018 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013735
