UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026644 |
|---|---|
| Receipt number | R000030371 |
| Scientific Title | Effect of the DPP-4 inhibitor, saxagliptin on glucose variability in type 2 diabetes patients with Chronic kidney disease |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/06/14 08:52:14 |
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Basic information
Public title
Effect of the DPP-4 inhibitor, saxagliptin on glucose variability in type 2 diabetes patients with Chronic kidney disease
Acronym
Effect of saxagliptin on glucose variability in type 2 diabetes patients with CKD
Scientific Title
Effect of the DPP-4 inhibitor, saxagliptin on glucose variability in type 2 diabetes patients with Chronic kidney disease
Scientific Title:Acronym
Effect of saxagliptin on glucose variability in type 2 diabetes patients with CKD
Region
| Japan |
Condition
Condition
Type 2 diabetes patients with CKD
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of saxagliptin on glucose variability and safety in type 2 diabetes patients with or without CKD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Mean Amplitude of Glycemic Excursions from baseline to week 4 after the start of administration
Key secondary outcomes
Change in glucose variability and biomakers from baseline to week 4 after the start of administration
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
Administration of saxagliptin 2.5mg or 5 mg once a day before breakfast.
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 diabetes
2. >=20 of age at the time of informed consent acquisition
3. HbA1c (NGSP) >=6.5% and <10.0%
4. The patients provided written informed consent to participate in the study
Key exclusion criteria
1. Patients who have history of hypersensitivity to saxagliptin or the other dpp-4 inhibitors
2. Patients who have history of administration of incretin-related drugs within 4 weeks
3. Patients who changed anti-diabetic drugs, diet thrapy or exercise thrapy within 4 weeks
4. Patients who have end stage renal disease undergoing maintenance dialysis, or after renal transplantation
5. Patients who have history of severe ketosis, diabetic coma, or precoma within 6 months
6. Patients who have history of cancer within 5 years
7. Patients who have liver disfunction with AST or ALT>=3 x upper limit of normal
8. Patients who experienced severe traumatotherapy requiring surgery or surgery with general anesthesia within 6 months
9. Women who is pregnant or planned to become pregnant
10. Patients who are considered not eligible for the study by the attending doctor due to other reasons
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tahashi Maruyama |
Organization
Nihon University Itabashi Hospital
Division name
Division of Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
maruyama.takashi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fujino |
Organization
Kyowa Hakko Kirin,co.,Ltd
Division name
Medical Affairs Department
Zip code
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
0352057200
Homepage URL
hiroshi.fujino@kyowa-kirin.co.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyowa Hakko Kirin,co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2017 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 22 | Day |
Last modified on
| 2018 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030371
