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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004791
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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