UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Crossover study to compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with other DPP-4 inhibitors
Title of the study (Brief title)	Randomized Crossover study to compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with other DPP-4 inhibitors
Region	Japan

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

Objectives
Narrative objectives1	To compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with the other DPP-4 inhibitors.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in HbA1c between the start and the fourth month and that between the fourth and the eighth month
Key secondary outcomes	Change in 1.5-AG, Urinary albumin (mg/gCr), and urinary protein (g/gCr) between the start and the fourth month and that between the fourth and the eighth month. Number of patients who choose either medicine on the eighth month. Change in HbA1c between the eighth and the 12th month.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In the first period(for four months from the start), the former DPP-4 inhibitor is changed to trelagliptin 100mg, in the second period( for four months from the fifth month) trelagliptin is changed to omarigliptin 25mg. The necessity of reduction of the medicine is judged by attending doctors. Questionnaire is carried out at the end of the fourth month and the eight month. At the end of the eight month patients are asked to choose the next DPP-4 inhibitor from trelagliptin, omarigliptin, the former DPP-4 inhibitor. When patients are not able to make up their mind, attending doctors are able to give advices.
Interventions/Control_2	In the first period(for four months from the start), the former DPP-4 inhibitor is changed to omarigliptin 25mg, in the second period( for four months from the fifth month) omarigliptin is changed totrelagliptin 100mg. The necessity of reduction of the medicine is judged by attending doctors. Questionnaire is carried out at the end of the fourth month and the eight month. At the end of the eight month patients are asked to choose the next DPP-4 inhibitor from trelagliptin, omarigliptin, the former DPP-4 inhibitor. When patients are not able to make up their mind, attending doctors are able to give advices.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes patients who have been treated with once or twice daily DPP-4 inhibitors for more than three months.
Key exclusion criteria	Type 1 diabetic patients. Patients with a history of severe ketosis or diabetic coma in previous 6 months. Patients with severe infection, before/after surgery or severe traumatic injury. Patients to have a plan to be pregnant. Patients with severe gastroenteric disturbance as exemplified by severe gastro-paresis. Patients with a history of pancreatitis
Target sample size	100

Research contact person
Name of lead principal investigator	Tatsuya Haga
Organization	Haga Diabetes Clinic
Division name	Internal Medicine
Address	3514-1 Teigaishinden Nishiho-cho Aisai Aichi Japan
TEL	0567-28-7700
Email	haga@fuga.ocn.ne.jp

Public contact
Name of contact person	Tatsuya Haga
Organization	Haga Diabetes Clinic
Division name	Internal Medicine
Address	3514-1 Teigaishinden Nishiho-cho Aisai Aichi Japan
TEL	0567-28-7700
Homepage URL
Email	haga@fuga.ocn.ne.jp

Sponsor
Institute	Haga Diabetes Clinic
Institute
Department

Funding Source
Organization	Haga Diabetes Clinic
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	羽賀糖尿病内科

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 29 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 12 Month 18 Day
Anticipated trial start date	2016 Year 01 Month 04 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
Date trial data considered complete	2019 Year 08 Month 31 Day
Date analysis concluded	2019 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 27 Day
Last modified on	2017 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031750