UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of sitagliptin on insulin secretion in Japanese type 2 diabetic patients.
Title of the study (Brief title)	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	Nobuya Inagaki
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Diabetes and Clinical Nutrition
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	Norio Harada
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Diabetes and Clinical Nutrition
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
Institute	Department of Diabetes and Clinical Nutrition, Graduate School of Medicine, Kyoto University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005701