UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of anagliptin on blood glucose and lipid levels in type 2 diabetes mellius
Title of the study (Brief title)	The hypoglycemic and lipidemic effect of anagliptin in type 2 diabetes mellius
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 on glycemic control and safty in patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Change of HbA1c and lipid levels
Key secondary outcomes	1) Achiemement rate of blood glucose <130mg/dl 2) The change of glycemic and lipid parameters. 3)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)HbA1c :more than 7.0%, less than 9% 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 vildagliptin, linagliptin, repaglinide and glimepiride severe infection, before operation, severe trauma 2)severe ketosis, diabetic coma within 6 months 3)severe hepatic dysfunction or severe renal dysfunction (SCr:more than 2.0mg/dl or eGFR less than 30) 4)pregnacy 5)Patients judged by the investigator to be ineligible for some other reason
Target sample size	100

Research contact person
Name of lead principal investigator	Tadashi Yamakawa
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	naibunpi@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person	Tadashi Yamakawa
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	naibunpi@urahp.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

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

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	2013 Year 12 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 11 Day
Anticipated trial start date	2013 Year 12 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The purpose of this study is to investigate the effect of anagliptin on glycemic control and safty in patients with type 2 diabetes.

Management information
Registered date	2013 Year 12 Month 09 Day
Last modified on	2017 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014669