UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007477 |
|---|---|
| Receipt number | R000008822 |
| Scientific Title | Study on usefulness of sitagliptin in patients with type 2 diabetes |
| Date of disclosure of the study information | 2012/03/09 |
| Last modified on | 2014/09/09 09:25:08 |
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Basic information
Public title
Study on usefulness of sitagliptin in patients with type 2 diabetes
Acronym
JUMP study (Januvia on renal biomarkers and blood pressure)
Scientific Title
Study on usefulness of sitagliptin in patients with type 2 diabetes
Scientific Title:Acronym
JUMP study (Januvia on renal biomarkers and blood pressure)
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes (nephropathy stage I-III)
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A prospective study of a DDP-4 inhibitor Januvia will be conducted in Japanese patients with type 2 diabetes (diabetic nephropathy stage I-III) to evaluate the efficacy in controlling blood glucose, reducing blood pressure, and improving diabetic nephropathy as well as safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change and %change in HbA1c after 12 months from baseline
Key secondary outcomes
Changes and %changes in the following parameters during the observation period
Office blood pressure
Home blood pressure (In principle, 7 values collected at each visit should be used for evaluation).
Body weight
Urinary albumin/creatinine
eGFR
Novel biomarkers including urinary megalin
Exploratory analyses
At the completion of the treatment period, stratified analyses based on background variables (status of monotherapy / combination therapy, age, and diabetic nephropathy stage, etc) will be conducted to evaluate the usefulness of Januvia in reducing blood glucose.
Moreover, its association with HbA1c, blood pressure, albuminuria, eGFR, and novel biomarkers will be analyzed.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who fulfill the following criteria will be included in the study:
1) Patients who had received diet / exercise therapy alone or diet / exercise therapy and antidiabetic agents for more than 4 weeks, and whose blood glucose has not been sufficiently controlled (HbA1c 6.5% or fasting blood glucose 130mg/dL or casual blood glucose 180mg/dL).
2) Patients with diabetic nephropathy at stage I (pre-nephropathy) to stage III (overt proteinuria).
3) Patients for whom change of concomitant drugs including antihypertensives is considered not necessary in principle for at least 6 months
4) Outpatients aged20 years of both sexes who have given written informed consent on use of their data
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from the study.
1) Patients with type 1 diabetes
2) Patients before or after operation, and those with severe infections or serious injury
3) Pregnant, possible pregnant, or lactating women
4) Patients with severe kidney dysfunction (serum creatinine2.5 mg/dL)
5) Patients with a history of hypersensitivity to Januvia
6) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Saito |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Applied Molecular Medicine
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL
025-227-0915
akisaito@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiko Saito |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Applied Molecular Medicine
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL
025-227-0915
Homepage URL
akisaito@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Research foundation for community medicine
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
新潟大学医歯学総合病院（新潟県）、新潟臨港病院（新潟県）、木戸病院（新潟県）、坂町病院（新潟県）、済生会三条病院（新潟県）、三条総合病院（新潟県）、小千谷総合病院（新潟県）、長岡赤十字病院（新潟県）、長岡中央綜合病院（新潟県）、六日町病院（新潟県）、小林医院（新潟県）、中新潟クリニック（新潟県）、鈴木内科小児科医院（新潟県）、村山内科（新潟県）、きくち内科医院（新潟県）、わかばやし内科クリニック（新潟県）、こばりファミリークリニック（新潟県）、えきまえクリニック内科はやし医院（新潟県）、林内科クリニック（新潟県）、岡田内科医院（新潟県）、いがらし内科医院（新潟県）、おおむら内科クリニック（新潟県）、押木内科神経内科医院（新潟県）、横田内科医院（新潟県）、笹川医院（新潟県）、小千谷総合病院附属十日町診療所（新潟県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | 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
| 2010 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
A prospective study of a DDP-4 inhibitor Januvia will be conducted in Japanese patients with type 2 diabetes (diabetic nephropathy stage I-III) to evaluate the efficacy in controlling blood glucose, reducing blood pressure, and improving diabetic nephropathy as well as safety.
Management information
Registered date
| 2012 | Year | 03 | Month | 09 | Day |
Last modified on
| 2014 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008822
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
