UMIN-CTR Clinical Trial

Public title

The effect of sitagliptin on insulin secretion in Japanese type 2 diabetic patients.

Acronym

Medical Approach by Incretin in KyotO Sitagliptin Anti-diabetic Study

Scientific Title

The effect of sitagliptin on insulin secretion in Japanese type 2 diabetic patients.

Scientific Title:Acronym

Medical Approach by Incretin in KyotO Sitagliptin Anti-diabetic Study

Region

Japan

Condition

Japanese type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to compare the efficacy of sitagliptin on insulin secretion with glimepilide in Japanese type 2 diabetes.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

insulinogenic index

Key secondary outcomes

1.HbA1c (%) (JDS value)
2.GA (%)
3.CPR/PG during OGTT
4.insulin/pro insulin rate
5.ISI composite=10000/(FPGxFIRIxmean OGTT PGxmean OGTT IRI)0.5
6.total GIP, total GLP-1 (pg/ml)
7.high-sensitive C-reactive protein (mg/)
8.total-Cho, LDL-Cho, HDL-Cho (mg/dl)
9.urinary albumin/creatinin (mg/g.Cr)
10.blood pressure (mmHg)
11.body weight (Kg)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The sitagliptin group is treated with sitagliptin in a range between 25mg (as a minimum dose) and 100mg (as a maximum dose) administrated once per day in the morning, for a period of 52 weeks.

Interventions/Control_2

The glimepilide group is treated with glimepilide in a range between 0.25mg (as a minimum dose) and 1.0mg (as a maximum dose) administrated once per day in the morning, for a period of 52 weeks.

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

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

The screening criteria of this study are as follows :
1.Japanese patients with type 2 diabetes
2.The glycemic inclusion criteria is less than HbA1c 8.0%,(They didn't exhibit decrease of HbA1c levels more than 1.0% in the last two months before the beginning of the study).
3.Age: Less than 80 years old.
4.No treatment with antidiabetic drugs for at least 1 months before the beginning of the study.

Key exclusion criteria

1.Patients who could not sign informed consent for this study.
2.Patients with history of malignancy.
3.Patients with severe complications as follows: dysfunction of heart, lung, liver, kidney and pancreas and cerebral vessel disease as well as infections.
4.Patients with severe diabetic complications, such as bleeding diabetic retinopathy, diabetic nephropathy (eGFR<30), diabetic neuropathy, gangrene, ketosis, diabetic pre-coma and diabetic coma.
5.Patients during pregnancy or possible pregnant women.
6.Patients with type 2 diabetes using other antidiabetic drugs.
7.Patients with gastrointestinal symptoms such as diarrhea and vomiting.
8.Patients who are inadequate to entry this study.
9.Patients with severe frequent hypoglycemia and condition of hypoglycemia-unconsciousness.
10.Patients who are treated or will be treated with drugs which increase blood glucose such as steroids, interferon and tacrolimus.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Nobuya Inagaki

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Diabetes and Clinical Nutrition

Zip code

Address

54 Shogoinkawahara-cho,Sakyo-ku,Kyoto 606-8507,Japan

TEL

075-751-3560

Email

inagaki@metab.kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Norio Harada

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Diabetes and Clinical Nutrition

Zip code

Address

54 Shogoinkawahara-cho,Sakyo-ku,Kyoto 606-8507,Japan

TEL

075-751-3560

Homepage URL

Email

nharada@metab.kuhp.kyoto-u.ac.jp

Institute

Department of Diabetes and Clinical Nutrition, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name

Organization

Japan Diabetes 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

2010

Year

12

Month

24

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2010

Year

12

Month

06

Day

Date of IRB

Anticipated trial start date

2011

Year

04

Month

01

Day

Last follow-up date

2013

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

12

Month

24

Day

Last modified on

2017

Year

03

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005701