UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011737
Receipt number R000013722
Scientific Title Comparison of glucose profiles of Insulin Lispro Mix 50 TID and Basal/Bolus Therapy in continuous glucose monitoring system.
Date of disclosure of the study information 2013/09/12
Last modified on 2013/09/12 17:37:29

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Basic information

Public title

Comparison of glucose profiles of Insulin Lispro Mix 50 TID and Basal/Bolus Therapy in continuous glucose monitoring system.

Acronym

Comparison of glucose profiles of Insulin Lispro Mix 50 TID and Basal/Bolus Therapy in continuous glucose monitoring system.

Scientific Title

Comparison of glucose profiles of Insulin Lispro Mix 50 TID and Basal/Bolus Therapy in continuous glucose monitoring system.

Scientific Title:Acronym

Comparison of glucose profiles of Insulin Lispro Mix 50 TID and Basal/Bolus Therapy in continuous glucose monitoring system.

Region

Japan


Condition

Condition

type2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of glucose profiles of Insulin Lispro Mix 50 TID and Basal/Bolus Therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HbA1c glucose profile

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


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

Interventions/Control_1

Basal/Bolus Therapy

Interventions/Control_2

Insulin Lispro Mix 50 TID

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

HbA1c7.0-11%
type2 diabetes

Key exclusion criteria

type1 diabetes

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naofumi Fukuda

Organization

Yamaguchi University Hospital

Division name

internal medicine 3

Zip code


Address

1-1-1 minamikogushi ube city yamaguchi ken

TEL

0836222563

Email

nfm6666@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naofumi Fukuda

Organization

Yamaguchi University Hospital

Division name

internal medicine 3

Zip code


Address

1-1-1 minamikogushi ube city yamaguchi ken

TEL

0836222563

Homepage URL


Email

nfm6666@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University Hospital

Institute

Department

Personal name



Funding Source

Organization

Yamaguchi University Hospital internal medicine 3

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

2013 Year 09 Month 12 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

Terminated

Date of protocol fixation

2010 Year 05 Month 11 Day

Date of IRB


Anticipated trial start date

2010 Year 08 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

2013 Year 09 Month 12 Day

Last modified on

2013 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013722


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name