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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038801
Receipt No. R000044236
Scientific Title Long-term efficacy and safety of the DPP-4 inhibitors in Japanese patients with type 2 diabetes mellitus.
Date of disclosure of the study information 2019/12/05
Last modified on 2019/12/05

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Basic information
Public title Long-term efficacy and safety of the DPP-4 inhibitors in Japanese patients with type 2 diabetes mellitus.
Acronym Long-term efficacy and safety of the DPP-4 inhibitors in Japanese patients with type 2 diabetes mellitus.
Scientific Title Long-term efficacy and safety of the DPP-4 inhibitors in Japanese patients with type 2 diabetes mellitus.
Scientific Title:Acronym Long-term efficacy and safety of the DPP-4 inhibitors in Japanese patients with type 2 diabetes mellitus.
Region
Japan

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

Objectives
Narrative objectives1 We retrospectively evaluated the long-term efficacy and safety of the DPP-4 inhibitors in Japanese patients with type 2 diabetes mellitus.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the change in the eGFR slope and urine albumin creatinine ratio
Key secondary outcomes Metabolic marker; HbA1c and body weight
Hemodynamic marker; systolic and diastolic blood pressure, and heart rate
Liver enzyme marker; AST, ALT and gamma-GTP
Liver fibrosis marker; Fib-4 index
Arteriosclerosis marker; IMT, PWV and ABI
Others; Uric acid and hemoglobin
Safety marker; incidence rate of Hypoglycemia, serum albumin level

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type 2 diabetes
Administration of DPP-4 inhibitors
Key exclusion criteria Participation in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Osonoi
Organization Nakakinen clinic
Division name Director
Zip code 311-0113
Address 745-5 Nakadai, Naka-shi, Ibaraki
TEL 029-353-2800
Email t-osonoi@kensei-kai.com

Public contact
Name of contact person
1st name Kensuke
Middle name
Last name Ofuchi
Organization Nakakinen clinic
Division name Department of clinical research
Zip code 311-0113
Address 745-5 Nakadai, Naka-shi, Ibaraki
TEL 029-353-2800
Homepage URL
Email k-ofuchi@kensei-kai.com

Sponsor
Institute Nakakinen clinic
Institute
Department

Funding Source
Organization Nakakinen clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nakakinen clinic
Address 745-5 Nakadai, Naka-shi, Ibaraki
Tel 029-353-2800
Email k-ofuchi@kensei-kai.com

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
2019 Year 12 Month 05 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 3000
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 No longer recruiting
Date of protocol fixation
2019 Year 11 Month 02 Day
Date of IRB
2019 Year 11 Month 21 Day
Anticipated trial start date
2019 Year 11 Month 02 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information Single facility retrospective observation study

Management information
Registered date
2019 Year 12 Month 05 Day
Last modified on
2019 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044236

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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