UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the clinical efficacy of anagliptin in type 2 diabetic patients with diabetic nephropathy.
Title of the study (Brief title)	Evaluation of the clinical efficacy of anagliptin in type 2 diabetic patients with diabetic nephropathy.
Region	Japan

Condition
Condition	Type 2 diabetes with diabetic nephropathy
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of anagliptin on the parameters of glycemic control, lipid profile and renal function in type 2 diabetic patients with diabetic nephropathy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in HbA1c
Key secondary outcomes	1.Lipid profile LDL-C HDL-C TG 2.Renal function ACR (Measurement using a first morning urine sample. Calculation of a geometric average ratio for analysis.) Serum Cr (Calculation of an estimated glomerular filtration rate.) Urine liver fatty acid-binding protein (L-FABP) Serum cystatin C (Cys-C)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	anagliptin
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Type 2 diabetic patients. 2.Outpatients, >= 20 years old (regardless of sex). 3.6.0% <= HbA1c <10.0%. 4.Patients who have not been treated with oral hypoglycemic agents for at least 12 weeks before the study, or patients treated with a stable dose of anti-diabetic medicines, including alpha-glucosidase inhibitors (alpha-GI), biguanide (BG), sulfonylurea (SU) or thiazolidine (TZD) for at least 12 weeks before the study. 5.30 <= urinary albumin/ creatinine ratio (ACR:mg/gCr) < 3000. (stage A2 [microalbuminuria] or A3 [microalbuminuria]) 6.Patients who are able to provide written informed consent.
Key exclusion criteria	1.Patient have been treated with DPP-4 inhibitors within 12 weeks before the study. 2.Patient have been treated with insulins, rapid acting insulin secretagogues, or a high dose of SU (glimepiride > 2mg/day, gliclazide > 40mg/day, glibenclamide > 1.25mg/day). 3.Patient who have a history of allergy to anagliptin. 4.Patients who have severe ketosis, diabetic coma, diabetic pre-coma, or type 1 diabetes 5.Patients who have severe infection,
Target sample size	50

Research contact person
Name of lead principal investigator	Daisuke Koya
Organization	Kanazawa Medical University
Division name	Diabetology and Endocrinology
Address	Daigaku1-1 Uchinadamachi Kahokugun Ishikawaken
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	Daigaku1-1 Uchinadamachi Kahokugun Ishikawaken
TEL	076-286-2211
Homepage URL
Email	naipicrc@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University Diabetology and Endocrinology
Institute
Department

Funding Source
Organization	The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	SANWA KAGAKU KENKYUSHO. CO., LTD.

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	2014 Year 01 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 04 Day
Anticipated trial start date	2013 Year 10 Month 17 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 09 Month 30 Day
Date trial data considered complete	2016 Year 09 Month 30 Day
Date analysis concluded	2016 Year 09 Month 30 Day

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

Management information
Registered date	2014 Year 01 Month 09 Day
Last modified on	2017 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014953