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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030532
Receipt No. R000034850
Scientific Title The effect of anagliptin on blood glucose and serum lipids in Patients with type 2 diabetes mellitus
Date of disclosure of the study information 2017/12/25
Last modified on 2019/07/01

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Basic information
Public title The effect of anagliptin on blood glucose and serum lipids in Patients with type 2 diabetes mellitus
Acronym The effect of anagliptin on blood glucose and serum lipids in patients with type 2 diabetes mellitus
Scientific Title The effect of anagliptin on blood glucose and serum lipids in Patients with type 2 diabetes mellitus
Scientific Title:Acronym The effect of anagliptin on blood glucose and serum lipids in 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 The purpose of this study is to investigate the effect of anagliptin from another DPP-4 inhibitor on blood glucose and lipid levels and in patients with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of HbA1c and lipid levels(LDL-C,MDA-LDL,RLP-C)
Key secondary outcomes 1. Change of HbA1c and lipid levels
2. The change of glycemic and lipid parameters
3. The analysis of baseline characteristics
4. The analysis of backgorund factors which affect glycemic and lipid control

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
85 years-old >
Gender Male and Female
Key inclusion criteria 1.Before test registration -anagliptin within 2 weeks outpatient
2. Type 2 diabetes
3. LDL-C more than 120 mg/dL
4. No plan to add other OHA
5. Age more than 20, less than 85
6. Patients with written IC
Key exclusion criteria 1. Allergy for anagliptin.
2. Severe ketosis, diabetic coma severe infection, before operation, severe trauma
3. Severe renal dysfunction including hemodialysis or peritoneal dialysis (SCr:more than 1.5mg/dl )
4. Pregnancy
5. Patients judged by the investigator to be ineligible for some other reason
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yoshihisa
Middle name
Last name Okamoto
Organization Japan Community Health care Organization, Yokohama Hodogaya Central Hospital
Division name Department of Medicine(Endocrinology, Diabetes and Metabolism)
Zip code 240-8585
Address 43-1 Kamadai-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8585, Japan
TEL 045-331-1251
Email okamoto-ykh@umin.ac.jp

Public contact
Name of contact person
1st name Yoshihisa
Middle name
Last name Okamoto
Organization Japan Community Health care Organization, Yokohama Hodogaya Central Hospital
Division name Department of Medicine(Endocrinology, Diabetes and Metabolism)
Zip code 240-8585
Address 43-1 Kamadai-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8585, Japan
TEL 045-331-1251
Homepage URL
Email okamoto-ykh@umin.ac.jp

Sponsor
Institute Japan Community Health care Organization, Yokohama Hodogaya Central Hospital
Institute
Department

Funding Source
Organization Self funding
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 Japan Community Health care Organization, Yokohama Hodogaya Central Hospital
Address 43-1 Kamadai-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8585, Japan
Tel 045-331-1251
Email ikeda-mitsuaki@hodogaya.jcho.go.jp

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
2017 Year 12 Month 25 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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 06 Day
Date of IRB
2017 Year 11 Month 06 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 12 Month 22 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034850

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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