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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005415
Receipt No. R000006425
Scientific Title Japan Prospective Long Term Clinical Trial in Type 2 Diabetes Patients with Sulfonyl Urea and Sitagliptin
Date of disclosure of the study information 2011/04/09
Last modified on 2016/04/09

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Basic information
Public title Japan Prospective Long Term Clinical Trial in Type 2 Diabetes Patients with Sulfonyl Urea and Sitagliptin
Acronym J-PLUS
Scientific Title Japan Prospective Long Term Clinical Trial in Type 2 Diabetes Patients with Sulfonyl Urea and Sitagliptin
Scientific Title:Acronym 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.

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

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
1st name
Middle name
Last name Kiminori HOSODA
Organization Kyoto University Graduate School of Medicine
Division name Department of Human Health Science
Zip code
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
1st name
Middle name
Last name Department of EBM Research
Organization Kyoto University Hospital
Division name iACT
Zip code
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

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)

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
2011 Year 04 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2011 Year 08 Month 30 Day
Date of IRB
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

Other
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-open-bin/ctr_e/ctr_view.cgi?recptno=R000006425

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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