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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012802
Receipt No. R000014953
Scientific Title Evaluation of the clinical efficacy of anagliptin in type 2 diabetic patients with diabetic nephropathy.
Date of disclosure of the study information 2014/01/09
Last modified on 2017/07/31

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Basic information
Public title Evaluation of the clinical efficacy of anagliptin in type 2 diabetic patients with diabetic nephropathy.
Acronym Evaluation of the clinical efficacy of anagliptin in type 2 diabetic patients with diabetic nephropathy.
Scientific Title Evaluation of the clinical efficacy of anagliptin in type 2 diabetic patients with diabetic nephropathy.
Scientific Title:Acronym 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
1st name
Middle name
Last name Daisuke Koya
Organization Kanazawa Medical University
Division name Diabetology and Endocrinology
Zip code
Address Daigaku1-1 Uchinadamachi Kahokugun Ishikawaken
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 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.

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

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 09 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
2013 Year 09 Month 04 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000014953

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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