UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001327
Receipt number R000001427
Scientific Title Jikei-EValuation of insulin Lispro mixture on pharmacodynamics and glycemic VariencE
Date of disclosure of the study information 2008/08/20
Last modified on 2010/08/20 18:29:02

* 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

Jikei-EValuation of insulin Lispro mixture on pharmacodynamics and glycemic VariencE

Acronym

J-EVOLVE

Scientific Title

Jikei-EValuation of insulin Lispro mixture on pharmacodynamics and glycemic VariencE

Scientific Title:Acronym

J-EVOLVE

Region

Japan


Condition

Condition

type 2 diabetes using insulin

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to test the difference between humalog 25 mix and humalog 50 mix using continuous glucose monitoring

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

continuous glucose values monitored for 24 hours

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

humalog mix 25

Interventions/Control_2

humalog mix 50

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

type 2 diabetes using humalog mix 25 or humalog mix 50

Key exclusion criteria

type 2 diabetes using insulin other than humalog mix 25 or humalog mix 50

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Rimei Nishimura

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, 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


TEL

03-3433-1111

Homepage URL


Email



Sponsor or person

Institute

Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

donation

Organization

Division

Category of Funding Organization

Profit organization

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

2008 Year 08 Month 20 Day


Related information

URL releasing protocol

http://www.cardiab.com/content/9/1/16

Publication of results

Published


Result

URL related to results and publications

http://www.cardiab.com/content/9/1/16

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

Completed

Date of protocol fixation

2008 Year 05 Month 08 Day

Date of IRB


Anticipated trial start date

2008 Year 06 Month 01 Day

Last follow-up date

2009 Year 10 Month 01 Day

Date of closure to data entry

2009 Year 11 Month 01 Day

Date trial data considered complete

2009 Year 12 Month 01 Day

Date analysis concluded

2010 Year 01 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 08 Month 20 Day

Last modified on

2010 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001427


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name