UMIN-CTR Clinical Trial

Public title

Sitagliptin Prospective study of Intima media thickness Evaluation Extension Study

Acronym

SPIKE Extension Study

Scientific Title

Sitagliptin Prospective study of Intima media thickness Evaluation Extension Study

Scientific Title:Acronym

SPIKE Extension Study

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of hypoglycemic therapy with a Dipeptidyl-Peptidase 4 (DPP-4) inhibitor sitagliptin for the risk of cardiovascular events, especially on, mortality ,
acute myocardial infarction and cerebral infarction by extending SPIKE study for 8 years.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluation of cardiovascular event rates (e.g. death, acute myocardial infarction, and cerebral infarction), and correlation between the use of sitagliptin and the events

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

30

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

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 less than 80 years (males and females)
3) Patients who have provided written consent to participate in the study
* Except for CSII

Key exclusion criteria

1) Patients with type 1 or secondary diabetes
2) Patients with severe infections, pre-/post-operative status, and 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 prescribed other incretin-based agents, including DPP-4 inhibitors, at study initiation
9) Patients taking diabetic medicines, etc., that are prohibited for combination with incretin-based agents including DPP-4 inhibitors, by health insurance, at 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

Name of lead principal investigator

1st name
Middle name
Last name	HIROTAKA WATADA

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Medicine,Metabolism and Endocrinology

Zip code

Address

2-1-1 Hongo,Bunkyo-ku,Tokyo

TEL

03-3813-3111

Email

hwatada@juntendo.ac.jp

Name of contact person

1st name
Middle name
Last name	TOMOYA MITA

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Medicine,Metabolism and Endocrinology

Zip code

Address

2-1-1 Hongo,Bunkyo-ku,Tokyo

TEL

03-3813-3111

Homepage URL

Email

tom-m@juntendo.ac.jp

Institute

Japan Cardiovascular Research foundation

Institute

Department

Personal name

Organization

Japan Cardiovascular Research foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

05

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2014

Year

02

Month

12

Day

Date of IRB

Anticipated trial start date

2014

Year

04

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

To evaluate the effects of hypoglycemic therapy with sitagliptin for risk of cardiovascular event, especially death, acute myocardial infarction and cerebral infarction, by 8 years extension of spike study .
Observed point is once a year.

Registered date

2014

Year

05

Month

20

Day

Last modified on

2016

Year

05

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016322