UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005415 |
|---|---|
| Receipt number | 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 11:13:33 |
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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 ≥1.5 mg/dL; female, serum creatinine ≥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
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
syasuno@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006425
