UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The intervention trial of safety and efficacy of once-weekly Trelagliptin switched from daily DPP4 inhibitors for elderly patients with type 2 diabetes
Title of the study (Brief title)	Safety and efficacy of Trelagliptin in elderly patients with type 2 diabetes
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm safety snd efficacy of Trelagliptin in elderly patients with type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Levels of glycohemoglobin at before and 12 weeks after switching
Key secondary outcomes	Blood pressure, abdominal circumference, weight,frequency and severity of hypoglycemia, liver function, renal function

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Trelagliptin 100 mg will be administered once a week for 12 weeks.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with type 2 diabetes who are administered daily DPP4 inhibitors over 65 years of age
Key exclusion criteria	Patients with renal dysfunction [creatinine clearance <50 ml/min or serum creatinine above 1.4 mg/dl(male), 1.2 mg/dl(female)] Patients using insulin or GLP-1 receptor agonists
Target sample size	30

Research contact person
Name of lead principal investigator	Takahiro Suzuki
Organization	Kanagawa-ken Keiyu-kai Keiyu hospital
Division name	Department of internal medicine
Address	3-7-3, Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan. 220-8521(Zip code)
TEL	045-221-8181
Email	t-suzuki@keiyu-hospital.com

Public contact
Name of contact person	Takahiro Suzuki
Organization	Kanagawa-ken Keiyu-kai Keiyu hospital
Division name	Department of internal medicine
Address	3-7-3, Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan. 220-8521(Zip code)
TEL	045-221-8181
Homepage URL
Email	t-suzuki@keiyu-hospital.com

Sponsor
Institute	Kanagawa-ken Keiyu-kai Keiyu hospital
Institute
Department

Funding Source
Organization	Kanagawa-ken Keiyu-kai Keiyu hospital
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

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 01 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

Management information
Registered date	2017 Year 02 Month 27 Day
Last modified on	2017 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030224