UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of omarigliptin on glucose excursion using continuous glucose monitoring in the elderly patients with type2 diabetes
Title of the study (Brief title)	The effect of omarigliptin on glucose excursion using CGM in the elderly patients with T2DM
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess efficacy and safety of omarigliptin in the elderly patients with type 2 diabetes mellitus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	glucose excursion using continuous glucose monitoring
Key secondary outcomes	fasting and postprandial glusoce fasting and postprandial CPR fasting and postprandial glucagon LDL-C TG HDL-C

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	omarigliptin 12.5mg or 25mg
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with type 2 diabetes, 60 years of age and older
Key exclusion criteria	Type 1 diabetes Severe liver dysfunction The subjects found offensive by attending physicians for this clinical research
Target sample size	10

Research contact person
Name of lead principal investigator	Yukio Horikawa
Organization	Gifu University Graduate School of Medicine
Division name	Department of Endoclinology
Address	1-1 yanagido, gifu, japan
TEL	058-230-6000
Email	yhorikaw@gifu-u.ac.jp

Public contact
Name of contact person	Yukio Horikawa
Organization	Gifu University Graduate School of Medicine
Division name	Department of Endoclinology
Address	1-1 yanagido, gifu, japan
TEL	058-230-6000
Homepage URL
Email	yhorikaw@gifu-u.ac.jp

Sponsor
Institute	Department of Endoclinology, Gifu University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Endoclinology, Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Yamada hospital
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	2016 Year 06 Month 10 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 05 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	2016 Year 04 Month 07 Day
Last modified on	2016 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025145