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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019273
Receipt No. 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

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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
Email 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
Email naipicrc@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022272

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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