UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034599
Receipt No. R000039444
Scientific Title Efficacy of alogliptin/metformin combination tablets(INISYNC combination tablets) in type 2 diabetic patients.
Date of disclosure of the study information 2018/10/22
Last modified on 2018/10/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of alogliptin/metformin combination tablets(INISYNC combination tablets) in type 2 diabetic patients.
Acronym Efficacy of alogliptin/metformin combination tablets(INISYNC combination tablets) in type 2 diabetic patients.
Scientific Title Efficacy of alogliptin/metformin combination tablets(INISYNC combination tablets) in type 2 diabetic patients.
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuji Kawaguchi
Organization Minami Osaka hospital
Division name Internal medicine
Zip code
Address 1-18-18,Higashikagaya,Suminoe-ku,Osaka-city,Osaka
TEL 0666850221
Email y.kawaguchi@minamiosaka.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Kawaguchi
Organization Minami Osaka hospital
Division name Internal medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.