UMIN-CTR Clinical Trial

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	shiratori-yutaka@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	Terminated
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	2022 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded	2022 Year 06 Month 30 Day

Other
Other related information	None

Management information
Registered date	2017 Year 12 Month 22 Day
Last modified on	2022 Year 06 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034850