UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034599 |
|---|---|
| Receipt number | 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 19:36:47 |
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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
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
y.kawaguchi@minamiosaka.com
Sponsor or person
Institute
Minami Osaka hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039444
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
