UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of Alogliptin and Metformin fixed-dose tablets once a morning vs. once an evening using Freestyle Libre Pro flash glucose Monitoring (AMPM study): An open-label randomized cross-over Trial.
Title of the study (Brief title)	Comparison of Alogliptin and Metformin fixed-dose tablets once a morning vs. once an evening using Freestyle Libre Pro flash glucose Monitoring (AMPM study): An open-label randomized cross-over Trial.
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of alogliptin benzoate and metformin hydrochloride combination tablets medication at morning/night on blood glucose.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the blood glucose area under the curve
Key secondary outcomes	1) Average glucose (AG) 2) Average daily risk range (ADRR) 3) Morbus (M) value 4) 3-h post prandial (breakfast, lunch, dinner) blood glucose area under the curve (AUC) 5) Blood glucose (< 70mg/dl) area on the curve (AOC)

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 Behavior,custom
Interventions/Control_1	Morning treatment alogliptin benzoate and metformin hydrochloride combination tablets medication
Interventions/Control_2	Evening treatment alogliptin benzoate and metformin hydrochloride combination tablets medication
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Age 20-70 years 2) Type 2 diabetes 3) HbA1c > 6.5%
Key exclusion criteria	1) Type 1 diabetes 2) Undergoing insulin or GLP-1 agonist treatment 3) shift worker or night worker 4) Contraindications of medicine (Cr => 1.3mg/dL for men and => 1.2mg/dL for women) 5) Patients have History of hyper sensitivity 6) Not suitable for paticipate in this study from medical reason judged by a doctor
Target sample size	20

Research contact person
Name of lead principal investigator	Ebara Futoshi
Organization	Iryohojin Sukoyaka Takadachuo Byoin
Division name	Department of the internal medicine
Address	2-6-5 TakaKohokutanishi, Kohoku-Ku, Yokohama-City, Kanagawa, Japan
TEL	+81-45-592-5557
Email	japansk@nifty.com

Public contact
Name of contact person	Ebara Futoshi
Organization	Iryohojin Sukoyaka Takadachuo Byoin
Division name	Department of the internal medicine
Address	2-6-5 TakaKohokutanishi, Kohoku-Ku, Yokohama-City, Kanagawa, Japan
TEL	+81-45-592-5557
Homepage URL
Email	japansk@nifty.com

Sponsor
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	Self funding
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	2018 Year 02 Month 23 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 26 Day
Anticipated trial start date	2017 Year 12 Month 26 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	2018 Year 02 Month 23 Day
Last modified on	2018 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034719