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

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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 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


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

Value
https://center6.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