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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026644
Receipt No. 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

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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
Email 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
Email hiroshi.fujino@kyowa-kirin.co.jp

Sponsor
Institute Nihon University Itabashi Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030371

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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