UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006577
Receipt number R000007788
Scientific Title JIKEI Comparing of Alogliptin and Sitagliptin Trial with continuous glucose monitoring.
Date of disclosure of the study information 2011/10/19
Last modified on 2013/04/13 16:44:54

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Basic information

Public title

JIKEI Comparing of Alogliptin and Sitagliptin Trial with continuous glucose monitoring.

Acronym

J-CAST

Scientific Title

JIKEI Comparing of Alogliptin and Sitagliptin Trial with continuous glucose monitoring.

Scientific Title:Acronym

J-CAST

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare glucose variability under treatment by Aloglirtin or sitagliptin using CGM in type 2 diabetes patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

glucose variability

Key secondary outcomes

side effect


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Alogliptin

Interventions/Control_2

Sitagliptin

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

type2 diabetes whose HbA1c is >6.5 and <9.0
under life style intervention + ordinal dosage of SU or metformin or alpha-glucosidase inhibitor treatment

Key exclusion criteria

type 1 diabetes
diabetic ketosis
infection
past history of abdominal operation
past history of ileus
renal failure
liver damage
on insulin treatment
past history of allergy against Sitagliptin or Mitiglinide
Cancer patient
Dialysis patien

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kiyotaka Andou

Organization

Jikei University School of Medicine

Division name

Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine

Zip code


Address

3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461 Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Jikei University School of Medicine

Division name

Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine

Zip code


Address

3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461 Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Jikei University School of Medicine
3-25-8 Nishishimbashi, Minato-ku, Tokyo
105-8461 Japan

Institute

Department

Personal name



Funding Source

Organization

Jikei University School of Medicine
3-25-8 Nishishimbashi, Minato-ku, Tokyo
105-8461 Japan

Organization

Division

Category of Funding Organization

Non profit foundation

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

2011 Year 10 Month 19 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

2011 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 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

2011 Year 10 Month 19 Day

Last modified on

2013 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007788


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name