UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of alogliptin/metformin combination tablets(INISYNC combination tablets) in type 2 diabetic patients.
Title of the study (Brief title)	Efficacy of alogliptin/metformin combination tablets(INISYNC combination tablets) in type 2 diabetic patients.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effectiveness of alogliptin/metformin combination tablets(INISYNC combination tablets) in type 2 diabetes patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	The changes in HbA1c from the start of administration up to 6 months
Key secondary outcomes	1)Body weight 2)Compliance 3)Comparison with pretreatment drugs

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	Type 2 diabetic patients who are taking out alogliptin/metformin combination tablets (INISYNC combination tablets) and outpatient.
Key exclusion criteria	1)Patients with a history of lactic acidosis. 2)Patients with moderate or severe renal dysfunction(eGFR<45mL/min/1.73m2). 3)Patients with severe liver dysfunction such as active hepatitis and liver cirrhosis. 4)Patients with heart failure and acute myocardial infarction, pulmonary embolism such as advanced disability cardiovascular system and lung function. 5)Patients with excessive alcohol intake. 6)Patients with severe infections, before and after surgery, serious trauma. 7)Patient with malignant disease. 8)Pregnant women or patients who may be pregnant.
Target sample size	120

Research contact person
Name of lead principal investigator	Yuji Kawaguchi
Organization	Minami Osaka hospital
Division name	Internal medicine
Address	1-18-18,Higashikagaya,Suminoe-ku,Osaka-city,Osaka
TEL	0666850221
Email	y.kawaguchi@minamiosaka.com

Public contact
Name of contact person	Yuji Kawaguchi
Organization	Minami Osaka hospital
Division name	Internal medicine
Address	1-18-18,Higashikagaya,Suminoe-ku,Osaka-city,Osaka
TEL	0666850221
Homepage URL
Email	y.kawaguchi@minamiosaka.com

Sponsor
Institute	Minami Osaka hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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 10 Month 22 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 10 Month 15 Day
Anticipated trial start date	2018 Year 10 Month 22 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry	2019 Year 03 Month 01 Day
Date trial data considered complete	2019 Year 03 Month 15 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	1)Investigate the change of HbA1c in patients receiving oral administration of alogliptin/metformin combination tablets(INISYNC combination tablets) retrospectively. 2)Consider whether or not there is a difference in efficacy due to medication adherence. 3)Consider whether there is a difference in effect by pretreatment.

Management information
Registered date	2018 Year 10 Month 22 Day
Last modified on	2018 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039444