UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan Prospective Long Term Clinical Trial in Type 2 Diabetes Patients with Sulfonyl Urea and Sitagliptin
Title of the study (Brief title)	J-PLUS
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety of Dipeptidyl peptidase-4 inhibitor, sitagliptin, on HbA1c, body weight, beta cell function and occurrence of hypoglycemic attack in uncontrolled type 2 diabetes treated with sulfonylurea, while attempting to reduce or discontinue sulfonylurea.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in HbA1c value
Key secondary outcomes	A) changes in value of the following datas from baseline to 12 months after treatment; fasting plasma glucose, total cholesterol, triglyceride, high density lipoprotein cholesterol, calculated low density lipoprotein cholesterol, body weight, C-peptide in the blood, proinsulin/insulin ratio, glucagon in the blood, leptin in the blood, and HOMA-beta, B) change in the dosage of sulfonylurea, C) occurrence of hypoglycemic attack, d) occurrence of adverse event.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	initiate sitagliptin at dose of 50mg/day under the treatment of sulfonylurea at the following recommended dose (glimepiride, 2mg/day or less; glibenclamide, 1.25mg/day or less; gliclazide, 40mg/day or less) reduce dose of sulfonylurea or discontinue treatment of sulfonylurea based on the decision by attending physician, whenever the HbA1c value decreases to the targeted level (<6.5% [JDS] or <6.9% [international standard]) increase dose of sitagliptin to 100mg/day when the HbA1c value dose is greater than the targeted level after 3 months of treatment. increase dose of sulfonylurea when the HbA1c value dose is greater than the targeted level after 6 months of treatment. not allowed to change the dosage and administration of biguanides or thiazolidine or alpha-glycosidase inhibitors during the follow-up period if patients took these medications at enrollment.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) treated with sulfonylurea or combination of sulfonylurea and biguanides, thiazolidine or alpha-glycosidase inhibitors for more than 3 months and not treated with DPP-4 inhibitors. 2) HbA1c value is between 6.5 and 8.0% [JDS] or between 6.9 and 8.4% [international standard]). 3) outpatients over 20 years old and under 80 regardless of sex. 4) obtained written informed consent and able to start intervention within 2 months.
Key exclusion criteria	1) severe ketosis, diabetic coma or precoma 2) moderate renal dysfunction (male, serum creatinine &#8805;1.5 mg/dL; female, serum creatinine &#8805;1.3 mg/dL ) 3) severe infection , pre- or post-operation, or severe traumatic injury 4) pregnancy, child bearing potential, or nursing 5) history of hypersensitivity to sitagliptin. 6) inadequate due to other reasons by attending physician's judgments
Target sample size	250

Research contact person
Name of lead principal investigator	Kiminori HOSODA
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Human Health Science
Address	54 Shogoin Kawahara-Cho, Sakyo-ku, Kyoto 606-8507
TEL	075-751-3172
Email	kh@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Department of EBM Research
Organization	Kyoto University Hospital
Division name	iACT
Address	54 Shogoin Kawahara-Cho, Sakyo-ku, Kyoto 606-8507
TEL	075-771-5153
Homepage URL
Email	syasuno@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan Vascular Disease Research 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	2011 Year 04 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 30 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2014 Year 12 Month 05 Day
Date of closure to data entry	2015 Year 01 Month 31 Day
Date trial data considered complete	2015 Year 04 Month 30 Day
Date analysis concluded	2015 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 04 Month 09 Day
Last modified on	2016 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000006425