UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of omarigliptin in type 2 diabetic patients
Acronym	The efficacy of omarigliptin in type 2 diabetic patients
Scientific Title	The efficacy of omarigliptin in type 2 diabetic patients
Scientific Title:Acronym	The efficacy of omarigliptin in type 2 diabetic patients
Region	Japan

Condition
Condition	Type2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy, the safety and the effect on QOL of omarigliptin in type2 diabetic patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The change in postprandial plasma glucose, glycated albumin and HbA1c three months after administration of omarigliptin
Key secondary outcomes	1. Body wight, blood pressure, body composition 2. Serum C peptide 3. Incidence of adverse events 4. Incidence of hypoglycemia 5. Medication adherence, QOL

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.Naive cases for DPP-4 inhibitor Patients with poor glycemic control on conventional therapy 2. Additional administration of omarigliptin Patients with poor glycemic control with drug treatment except for DPP-4 inhibitor 3. Cases whose treatment is changed from other DPP-4 inhibitors Criteria of poor glycemic control: HbA1c level exceeding 7.0% and/or glycated albumin level exceeding 21.0%
Key exclusion criteria	Patients having infectious diseases, thyroid disease, or malignant tumors. Patients being treated with steroids and changing the dosage. Patients considering not eligible for this trial by attending doctors due to any medical reasons.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yuriko Middle name Last name Izumi
Organization	Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Division name	Department of Pharmacy
Zip code	770-8548
Address	1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL	088-631-0110
Email	y.izumi@khg.or.jp

Public contact
Name of contact person	1st name Machiko Middle name Last name Komatsu
Organization	Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Division name	Department of diabetes mellitus
Zip code	770-8548
Address	1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL	088-631-0110
Homepage URL
Email	machikomatsu@r7.dion.ne.jp

Sponsor
Institute	Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
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)

IRB Contact (For public release)
Organization	Kawashima Hospital Ethics Review Committee
Address	1-1-39 Kitasako, Tokushima, 770-8548, Japan
Tel	088-631-0110
Email	sasaka@khg.or.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	川島病院（徳島県）、川島透析クリニック（徳島県）、鴨島川島クリニック（徳島県）、鳴門川島クリニック（徳島県）、脇町川島クリニック（徳島県）、阿南川島クリニック（徳島県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 28 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	41
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	No longer recruiting
Date of protocol fixation	2017 Year 03 Month 07 Day
Date of IRB	2017 Year 03 Month 07 Day
Anticipated trial start date	2017 Year 03 Month 28 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design: case series study Recruitment of target people: All patients who consulted our facilities from March 2017 through March 2022 and meet the inclusion/exclusion criteria Parameters: Plasma glucose, glycated albumin, HbA1c, serum C peptide Body weight, blood pressure, body composition Medication adherence, QOL Incidence of adverse events and hypoglycemia

Management information
Registered date	2017 Year 03 Month 25 Day
Last modified on	2019 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030555