UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To investigate DPP-4 inhibitors type dependent effects on antifibrotic miRNA and biomarkers.
Title of the study (Brief title)	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	Daisuke Koya
Organization	Kanazawa Medical University
Division name	Diabetology and Endocrinology
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	Yuka Kuroshima
Organization	Kanazawa Medical University
Division name	Diabetology and Endocrinology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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