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

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 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


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

Value
https://center6.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