UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040960 |
|---|---|
| Receipt number | R000046777 |
| Scientific Title | Effect of switch from metformin / vildagliptin fixed-dose combination tablet to metformin / anagliptin fixed-dose combination tablet |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2021/03/04 14:27:59 |
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Basic information
Public title
Effect of switch from EquMet combination tablet to METOANA combination tablet
Acronym
Effect of switch from EquMet combination tablet to METOANA combination tablet
Scientific Title
Effect of switch from metformin / vildagliptin fixed-dose combination tablet to metformin / anagliptin fixed-dose combination tablet
Scientific Title:Acronym
Effect of switch from metformin / vildagliptin fixed-dose combination tablet to metformin / anagliptin fixed-dose combination tablet
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 clinical outcomes of biguanide / DPP-4 inhibitor fixed-dose combination tablet effect by comparing the patients who switched from metformin / vildagliptin fixed-dose combination tablet to metformin / anagliptin fixed-dose combination tablet with the patients who continued metformin / vildagliptin fixed-dose combination tablet. The clinical outcomes are also estimated stratified by renal function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Time-dependent change in HbA1c in switch group and non-switch group
Key secondary outcomes
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
1. Patients with type 2 diabetes mellitus
2. Male and female aged of 20 years or older
3. Patients who switched from metformin / vildagliptin fixed-dose combination tablet (twice daily) to metformin / anagliptin fixed-dose combination tablet (twice daily) in Kurihara Clinic of Internal Medicine between November 21st, 2018 and March 31st, 2019, and continued visiting the clinic for 6 months or longer (switch group)
4. Patients who continued metformin / vildagliptin fixed-dose combination tablet (twice daily) after the first test between November 21st, 2018 and March 31st, 2019, and continued visiting Kurihara Clinic of Internal Medicine for 6 months or longer (non-switch group)
5. Patients who continued metformin / vildagliptin fixed-dose combination tablet (twice daily) for 3 months or longer before the switch to metformin / anagliptin fixed-dose combination tablet in switch group or before the first test in non-switch group
Key exclusion criteria
1. Patients who are treated by combination of metformin / vildagliptin fixed-dose combination tablet LD and HD
2. Patients who changed the dose of metformin / vildagliptin fixed-dose combination tablet during the metformin / vildagliptin fixed-dose combination tablet administration period
3. Patients who changed the dose of metformin / anagliptin fixed-dose combination tablet during the metformin / anagliptin fixed-dose combination tablet administration period
4. Patients who changed the type or dose of hypoglycemic agents or antihyperlipidemic agents
5. Patients who are treated by dialysis or patients with severe renal impairment (eGFR < 30 mL/min/1.73m2) at baseline
6. Female patients who are pregnant, breastfeeding, possibly pregnant, or planning to become pregnant
7. Patients who denied the use of clinical medical records to the study
8. Patients with any conditions that physicians thought to be inappropriate to participate in the study such as poor adherence
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Kurihara |
Organization
Kurihara Clinic of Internal Medicine
Division name
Internal Medicine
Zip code
004-0053
Address
7-28,3-jo 5-chome, Atsubetsu-Chuo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL
0118923522
ykuri@yg7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Kurihara |
Organization
Kurihara Clinic of Internal Medicine
Division name
Internal Medicine
Zip code
004-0053
Address
7-28,3-jo 5-chome, Atsubetsu-Chuo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL
0118923522
Homepage URL
ykuri@yg7.so-net.ne.jp
Sponsor or person
Institute
Kurihara Clinic of Internal Medicine
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
Kyoyukai RiverSide Clinic
Address
2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel
011-521-2321
rinrishinsa@riversideclinic.or.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 | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://lifescience.co.jp/tr/21/tr2101.html
Number of participants that the trial has enrolled
142
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 21 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 06 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046777
| 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 |
