UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012802 |
|---|---|
| Receipt number | 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 18:40:35 |
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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
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
naipicrc@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Diabetology and Endocrinology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014953
