UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034951 |
|---|---|
| Receipt number | R000039852 |
| Scientific Title | Comparison of once-daily alogliptin/metformin combination tablets and twice-daily anagliptin/metformin combination tablets switching from twice-daily metformin in Japanese type 2 diabetic patients |
| Date of disclosure of the study information | 2018/11/20 |
| Last modified on | 2022/04/20 21:34:19 |
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Basic information
Public title
Comparison of once-daily alogliptin/metformin combination tablets and twice-daily anagliptin/metformin combination tablets switching from twice-daily metformin in Japanese type 2 diabetic patients
Acronym
Comparison of once-daily INISYNC combination tablets and twice-daily METOANA combination tablets LD switching from twice-daily metformin in Japanese type 2 diabetic patients
Scientific Title
Comparison of once-daily alogliptin/metformin combination tablets and twice-daily anagliptin/metformin combination tablets switching from twice-daily metformin in Japanese type 2 diabetic patients
Scientific Title:Acronym
Comparison of once-daily INISYNC combination tablets and twice-daily METOANA combination tablets LD switching from twice-daily metformin in Japanese 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
The aim of this study is to compare the efficacy of once-daily alogliptin/metformin combination tablets and twice-daily anagliptin/metformin combination tablets switching from twice-daily metformin on glycemic control in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Comparing the two groups change in HbA1c over the 12-week treatment period, with a non-inferiority margin of 0.4%
Key secondary outcomes
1. Medication adherence
2. Fasting blood glucose (mg/dL)
3. Body weight (kg)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
switching from twice-daily 250mg-metformin to once-daily 25mg-alogliptin/250mg-metformin combination tablets over 12 weeks
Interventions/Control_2
switching from twice-daily 250mg-metformin to twice-daily 100mg-anagliptin/250mg-metformin combination tablets over 12 weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with type 2 diabetes ; age between 20 and 75 years
2) Patients with twice-daily 250mg-metformin more than 8 weeks before intervention
3) Patients who showed HbA1c levels 7.0% to 11.0% after 8 weeks metformin therapy
4) Patients without change of oral anti-diabetic medications over 8 weeks before intervention
Key exclusion criteria
1) Patients with DPP-4 inhibitor, GLP-1 receptor agonist, or insulin therapy
2) Patients with severe renal dysfunction (eGFR <30ml/min/1.73m2)
3) Patients with severe liver dysfunction
4) Patients with severe infection, operation, trauma
5) Patients with steroid medication
6) Patients who have pregnancy or possibilty of pregnancy, or are under lactation
7) Patients who have hypersensitivity to metformin, alogliptin, or anagliptin
8) Patients who are considered to be not eligible to the study by the doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Takano |
Organization
Fujisawa City Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
251-8550
Address
2-6-1, Fujisawa, Fujisawa-shi, Kanagawa, Japan
TEL
0466-25-3111
takanot460121@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Yamazaki |
Organization
Fujisawa City Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
251-8550
Address
2-6-1, Fujisawa, Fujisawa-shi, Kanagawa, Japan
TEL
0466-25-3111
Homepage URL
yamazaki-s@umin.ac.jp
Sponsor or person
Institute
Fujisawa City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujisawa City Hospital
Address
2-6-1, Fujisawa, Fujisawa-shi, Kanagawa, Japan
Tel
0466-25-3111
yamazaki-s@umin.ac.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
| 2018 | Year | 11 | Month | 20 | 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
48
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
| 2018 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039852
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| Registered date | File name |
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