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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034951
Receipt No. 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 2019/06/17

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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 plasma glucose (mg/dL)
3. Body weight (kg)
4. Lipid profile
5. The score of DTSQ (Diabetes Treatment Satisfaction Questionnaire)

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% or more 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 Diabetology and Endocrinology
Zip code 251-8550
Address 2-6-1, Fujisawa, Fujisawa-shi, Kanagawa, Japan
TEL 0466-25-3111
Email 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 Diabetology and Endocrinology
Zip code 251-8550
Address 2-6-1, Fujisawa, Fujisawa-shi, Kanagawa, Japan
TEL 0466-25-3111
Homepage URL
Email yamazaki-s@umin.ac.jp

Sponsor
Institute Fujisawa City Hospital
Institute
Department

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
Email 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
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 11 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 20 Day
Last follow-up date
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
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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