UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of teneligliptin in patients with type 2 diabetes mellitus
Title of the study (Brief title)	The efficacy of teneligliptin in patients with type 2 diabetes mellitus
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy, the safety of teneligliptin switched from linagliptin in type2 diabetic patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Amount of change in HbA1c after administration 24 weeks later
Key secondary outcomes	Casual blood glucose, glycoalbumin Serum lipid level(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol) Urinary albumin, urinary L-FABP The incidence of side effects

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	1.Patients with type 2 diabetes with HbA1c=> 7% at the time of consenting 2.Female and male patients over 20 years old 3.Patients have been taking daily linagliptin for more than 12 weeks 4.Patients who can provide their written consent for participation of this study
Key exclusion criteria	1.Patients with history of hypersensitivity to teneligliptin 2.Patients with diabetic ketoacidosis, diabetic coma, or bofore coma, type1 diabetes 3.Severe infection, before and not long after surgery, or patient with severe trauma 4.Women with during pregnancy , nursing, or pregnant likelihood 5.Patients with severe renal dysfunction ,end stage renal disease during dialysis 6.Patients with severe liver dysfunction 7.Inadequte patient judged by doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Hajime Koyano
Organization	Juntendo University Urayasu Hospital
Division name	Endocrinology and Diabetology
Address	2-1-1 Tomioka, Urayasu-city, Chiba 279-0021
TEL	047-353-3111
Email	hkoyano@juntendo.ac.jp

Public contact
Name of contact person	Hajime Koyano
Organization	Juntendo University Urayasu Hospital
Division name	Endocrinology and Diabetology
Address	2-1-1 Tomioka, Urayasu-city, Chiba 279-0021
TEL	047-353-3111
Homepage URL
Email	koyano@juntendo-urayasu.jp

Sponsor
Institute	Juntendo University Urayasu Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	順天堂大学医学部附属浦安病院（千葉県）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 28 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 05 Month 15 Day
Anticipated trial start date	2017 Year 08 Month 28 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	none

Management information
Registered date	2017 Year 08 Month 21 Day
Last modified on	2019 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032901