UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019273 |
|---|---|
| Receipt number | R000022272 |
| Scientific Title | To investigate DPP-4 inhibitors type dependent effects on antifibrotic miRNA and biomarkers. |
| Date of disclosure of the study information | 2015/10/08 |
| Last modified on | 2018/02/02 09:40:39 |
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Basic information
Public title
To investigate DPP-4 inhibitors type dependent effects on antifibrotic miRNA and biomarkers.
Acronym
DPP-4 inhibitors and antifibrotic biomarkers.
Scientific Title
To investigate DPP-4 inhibitors type dependent effects on antifibrotic miRNA and biomarkers.
Scientific Title:Acronym
DPP-4 inhibitors and antifibrotic biomarkers.
Region
| Japan |
Condition
Condition
Type 2 diabetic patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Each DPP4 inhibitors displays its unique pharmacokinetics. In this study we recruit the Diabetic patients with DPP-4 inhibitor treatment and investigate the potential difference in the plasma/urine biomarkers-associated with tissue fibrosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Plasma and urine DPP-4 activation
2)Antifibrotic miRNAs
3)Antifibrotic peptides
4)Urine IFN-gamma, IL-1 beta, sTNF-alpha reeptor1/2, IL-6, beta 2microglobulin, NAG, typeIV collagen
0 and 3 month after joining this study
Key secondary outcomes
1)Parameters of blood glucose (HbA1c, fasting blood glucose, glycoalbumin, insulin)
2)Urinary albumin excretion
3)eGFRcreat (calculation by conversion formula of GFRcreat in Japanese),
serum creatinine
4)Urinary L-FABP excretion, serum cystatin C (Cys-C), eGFRcys (calculation by conversion formula of eGFRcys in Japanese)
5) Serum lipid (T-cho, LDL, HDL, TG)
6)Blood pressure, pulse
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dose increment of Sitagliptin (50mg to 100mg)
Interventions/Control_2
Change Sitagliptin 50mg to Linagliptin 5mg
Interventions/Control_3
Change Alogliptin 25mg to Linagliptin 5mg
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)More than 20 years to less than 80 years old patient, at the time of obtaining the informed consent, (Gender, outpatient and hospitalization unquestioned)
(2)Type 2 diabetes patients.
(3)Patients with poorly controlled type 2 diabetes who take DPP-4
inhibitors Sitagliptin(50mg), Alogliptin (25) or Linagliptin(5)
(4)Patients whose HbA1c is 7.0% <=
HbA1c < 10.0% at the enrollment
(5)Patients with diabetic
nephropathy whose urinary albumin excretion (UAE) is >= 30 mg/gCr
(6)Patients with diabetic
nephropathy whose eGFRcreat is >= 30 mL/min/1.73m2
(7)Patients without changing the
kind and doses of medications during the last 3 months before the enrollment
(8)Patients who fully understand purpose, contents, anticipated adverse events , and risks of this clinical trial and patients with willingness to comply with the study and sign a written informed consent
Key exclusion criteria
(1)Patient who have a history of allergy to Linagliptin or Sitagliptin.
(2)Patients who have severe ketosis, diabetic coma, diabetic pre-coma, or type 1 diabetes
(3)Patients who have severe infection, surgery, planned surgery, severe trauma.
(4)Women who are pregnant, or possibility of pregnant, or wish to pregnant, or lactating.
(5)Patients with transit disorder in the digestive tract or peptic ulcer and esophageal varix (this product may irritate affected area.) and patients whom physician judges as inappropriate
(6)Patients with a predisposition to severe and habitual constipation (this product may exacerbate constipation) and patients whom physician judges as inappropriate
(7)Patients who are considered unsuitable for inclusion by the attending physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Koya |
Organization
Kanazawa Medical University
Division name
Diabetology and Endocrinology
Zip code
Address
1-1Daigaku,Uchinada,Kahoku-gun, Ishikawa Prefecture, 920-0293
TEL
076-286-2211
koya0516@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Kuroshima |
Organization
Kanazawa Medical University
Division name
Diabetology and Endocrinology
Zip code
Address
1-1Daigaku,Uchinada,Kahoku-gun, Ishikawa Prefecture, 920-0293
TEL
076-286-2211
Homepage URL
naipicrc@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
金沢医科大学病院 / Kanazawa Medical University Hospital.
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 08 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 08 | Day |
Last modified on
| 2018 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022272
