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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007477
Receipt No. 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

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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
Email 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
Email akisaito@med.niigata-u.ac.jp

Sponsor
Institute Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008822

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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