UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031445 |
|---|---|
| Receipt number | 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 13:34:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
japansk@nifty.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034719
