UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004791
Receipt number R000005701
Scientific Title The effect of sitagliptin on insulin secretion in Japanese type 2 diabetic patients.
Date of disclosure of the study information 2010/12/24
Last modified on 2017/03/29 14:01:18

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Basic information

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

Condition

Japanese type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

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)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

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

Institute

Department

Personal name



Funding Source

Organization

Japan Diabetes Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

2010 Year 12 Month 24 Day


Related information

URL releasing protocol


Publication of results

Published


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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name