UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041979 |
|---|---|
| Receipt number | R000047914 |
| Scientific Title | Effects of anagliptin / metformin hydrochloride combination tablets in patients with type 2 diabetes: a retrospective observational study |
| Date of disclosure of the study information | 2020/10/02 |
| Last modified on | 2021/11/30 09:54:54 |
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Basic information
Public title
Effects of anagliptin/metformin combination tablets: a retrospective observational study
Acronym
Effects of anagliptin/metformin combination tablets: a retrospective observational study
Scientific Title
Effects of anagliptin / metformin hydrochloride combination tablets in patients with type 2 diabetes: a retrospective observational study
Scientific Title:Acronym
Effects of anagliptin / metformin hydrochloride combination tablets in patients with type 2 diabetes: a retrospective observational study
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of anagliptin / metformin hydrochloride combination tablets in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c
Key secondary outcomes
1.Change in LDL-C
2.Change in HDL-C
3.Change in eGFR
4.Change in body weight, BMI and body composition
5.Incidence of adverse events
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with type 2 diabetes
2. Patients who started receiving of anagliptin / metformin hydrochloride combination tablets from November 21st, 2018 to May 31st, 2020 (data collection period) and continued for more than 12 weeks
Key exclusion criteria
1. Patients who received antidiabetic drugs for less than 8 weeks before switch to anagliptin / metformin hydrochloride combination tablets
2. Patients who denied the use of clinical medical records to the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Fukuda |
Organization
Fukuda Clinic
Division name
Internal Medicine
Zip code
532-0003
Address
2F Shin-Osaka Brick Building, 1-6-1, Miyahara, Yodogawa-ku, Osaka-shi, Osaka Japan
TEL
06-6398-0203
fukuda@drmog.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Fukuda |
Organization
Fukuda Clinic
Division name
Internal Medicine
Zip code
532-0003
Address
2F Shin-Osaka Brick Building, 1-6-1, Miyahara, Yodogawa-ku, Osaka-shi, Osaka Japan
TEL
06-6398-0203
Homepage URL
https://dmclinic.jp
fukuda@drmog.jp
Sponsor or person
Institute
Fukuda Clinic
Institute
Department
Personal name
Funding Source
Organization
SANWA KAGAKU KENKYUSHO CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Physicians Association Institutional Review Board
Address
Tokyo Medical Association Building 4F, 2-5, Kanda-Surugadai, Chiyoda, Tokyo, 101-0062, Japan
Tel
03-3259-6177
irb@nichirinnai.jp
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
| 2020 | Year | 10 | Month | 02 | 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
90
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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study retrospectively collects the medical records in patients with type 2 diabetes who received anagliptin / metformin hydrochloride combination tablets in Fukuda Clinic, and evaluates the clinical outcomes.
Management information
Registered date
| 2020 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047914
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
