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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031445
Receipt No. R000034719
Scientific Title Comparison of Alogliptin and Metformin fixed-dose tablets once a morning vs. once an evening using Freestyle Libre Pro flash glucose Monitoring (AMPM study): An open-label randomized cross-over Trial.
Date of disclosure of the study information 2018/02/23
Last modified on 2018/02/23

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Basic information
Public title Comparison of Alogliptin and Metformin fixed-dose tablets once a morning vs. once an evening using Freestyle Libre Pro flash glucose Monitoring (AMPM study): An open-label randomized cross-over Trial.
Acronym Comparison of Alogliptin and Metformin fixed-dose tablets once a morning vs. once an evening using Freestyle Libre Pro flash glucose Monitoring (AMPM study): An open-label randomized cross-over Trial.
Scientific Title Comparison of Alogliptin and Metformin fixed-dose tablets once a morning vs. once an evening using Freestyle Libre Pro flash glucose Monitoring (AMPM study): An open-label randomized cross-over Trial.
Scientific Title:Acronym Comparison of Alogliptin and Metformin fixed-dose tablets once a morning vs. once an evening using Freestyle Libre Pro flash glucose Monitoring (AMPM study): An open-label randomized cross-over Trial.
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of alogliptin benzoate and metformin hydrochloride combination tablets medication at morning/night on blood glucose.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the blood glucose area under the curve
Key secondary outcomes 1) Average glucose (AG)
2) Average daily risk range (ADRR)
3) Morbus (M) value
4) 3-h post prandial (breakfast, lunch, dinner) blood glucose area under the curve (AUC)
5) Blood glucose (< 70mg/dl) area on the curve (AOC)

Base
Study type Interventional

Study design
Basic design Cross-over
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 Behavior,custom
Interventions/Control_1 Morning treatment alogliptin benzoate and metformin hydrochloride combination tablets medication
Interventions/Control_2 Evening treatment alogliptin benzoate and metformin hydrochloride combination tablets medication
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Age 20-70 years
2) Type 2 diabetes
3) HbA1c > 6.5%
Key exclusion criteria 1) Type 1 diabetes
2) Undergoing insulin or GLP-1 agonist treatment
3) shift worker or night worker
4) Contraindications of medicine (Cr => 1.3mg/dL for men and => 1.2mg/dL for women)
5) Patients have History of hyper sensitivity
6) Not suitable for paticipate in this study from medical reason judged by a doctor
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ebara Futoshi
Organization Iryohojin Sukoyaka Takadachuo Byoin
Division name Department of the internal medicine
Zip code
Address 2-6-5 TakaKohokutanishi, Kohoku-Ku, Yokohama-City, Kanagawa, Japan
TEL +81-45-592-5557
Email japansk@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Ebara Futoshi
Organization Iryohojin Sukoyaka Takadachuo Byoin
Division name Department of the internal medicine
Zip code
Address 2-6-5 TakaKohokutanishi, Kohoku-Ku, Yokohama-City, Kanagawa, Japan
TEL +81-45-592-5557
Homepage URL
Email japansk@nifty.com

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization Self funding
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
Address
Tel
Email

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 02 Month 23 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 Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 26 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 02 Month 23 Day
Last modified on
2018 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034719

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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