UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028664
Receipt number R000032810
Scientific Title Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM) - SPIKE Sub Study -
Date of disclosure of the study information 2017/08/15
Last modified on 2018/02/16 17:39:29

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Basic information

Public title

Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM)
- SPIKE Sub Study -

Acronym

Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM)
- SPIKE Sub Study -

Scientific Title

Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM)
- SPIKE Sub Study -

Scientific Title:Acronym

Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM)
- SPIKE Sub Study -

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The effects of glucose-lowering therapy with a DPP-4 inhibitor (Sitagliptin) on the progression of arteriosclerosis will be investigated in clinical cases based on comparison with a conventional treatment group without DPP-4 inhibitor treatment through analyses of existing data from "Study of Preventive Effects of Sitagliptin on Diabetic Atherosclerosis" (observation period completed, data fixed) in this study. A surrogate marker of cardiovascular events, the semi-quantitative index of carotid artery wall tissue characterization, gray-scale median (GSM) will be measured, and the inhibition of arteriosclerosis progression will be compared.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Amount of change in gray-scale median (GSM) during the 2-year observation period

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

30 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria are included in this study.
1. Patients with type 2 diabetes (HbA1c [JDS value] of 6.6% or above) who do not show achievement of the target for glycemic control defined in the "Treatment Guide for Diabetes 2010" despite the three or more months of insulin therapy* (one to four injections per day during treatment with rapid-acting, ultra-rapid-acting, long-acting, intermediate-acting, or mixed insulin) or insulin therapy combined with oral diabetic agents other than DPP-4 inhibitors. Those who had previously used DPP-4 inhibitors but have not taken them for the recent twelve or more weeks are also included.

2. Patients aged 30 or older and younger than 80 years old (males and females)

3. Patients who have provided written consent to participate in the study

*Excluding CSII

Key exclusion criteria

Patients who fall into any of the following criteria are excluded from participating in the study.
1. Patients with type 1 or secondary diabetes

2. Patients with severe infections, pre-/post-operative status, or serious injuries

3. Patients with previous events of myocardial infarction, angina pectoris, stroke, or cerebral infarction

4. Patients complicated with diabetic retinopathy requiring retinal photocoagulation or crystalline lens surgery, or those who have undergone these treatments within the last one year

5. Patients with moderate or more severe renal dysfunction (serum creatinine [mg/dL] > 1.4 [male] or > 1.2 [female])

6. Patients with severe liver dysfunction (AST: 100 IU/l or above)

7. Patients with moderate or more severe heart failure (NYHA [New York Heart Association] class of III or above)

8. Patients who are prescribed with incretin-based agents, including other DPP-4 inhibitors at the time of commencement of the study

9. Patients taking diabetic medicines, etc., that are prohibited for combination with incretin-based agents including DPP-4 inhibitors, by health insurance, at the study initiation

10. Patients who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant

11. Patients with previous hypersensitivity to the investigated drug

12. Other patients determined ineligible by an investigator

Target sample size

274


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoto Katakami

Organization

Osaka University Graduate School of Medicine

Division name

Department of Metabolic Medicine

Zip code


Address

2-2 Yamadaoka, Suita-shi, Osaka

TEL

06-6879-3732

Email

katakami@endmet.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Takayama

Organization

Soiken Inc.

Division name

Clinical Study Support Division

Zip code


Address

NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo

TEL

03-3295-1350

Homepage URL


Email

takayama@soiken.com


Sponsor or person

Institute

Department of Metabolic Medicine, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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 08 Month 15 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

2016 Year 07 Month 05 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a retrospective study which analyzes the existing data of patients who were enrolled in the "Sitagliptin Prospective study of Intima media thickness Evaluation" (SPIKE study) UMIN000007396 starting on February 1st, 2012 (observation period has completed, data are fixed). Data are evaluated for the treatment effectiveness of sitagliptin to suppress the progression of diabetic atherosclerosis.


Management information

Registered date

2017 Year 08 Month 15 Day

Last modified on

2018 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032810


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name