UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016628
Receipt number R000019060
Scientific Title The comparative study of efficacy and safety in the treatment with mixed-type insulin to combined therapy with long-acting insulin analog and GLP-1 recepter agonist in type 2 DM.
Date of disclosure of the study information 2015/02/25
Last modified on 2017/02/27 11:20:08

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Basic information

Public title

The comparative study of efficacy and safety in the treatment with mixed-type insulin to combined therapy with long-acting insulin analog and GLP-1 recepter agonist in type 2 DM.

Acronym

The comparative study from mixed-type insulin to long-acting insulin analog and GLP-1 recepter agonist.

Scientific Title

The comparative study of efficacy and safety in the treatment with mixed-type insulin to combined therapy with long-acting insulin analog and GLP-1 recepter agonist in type 2 DM.

Scientific Title:Acronym

The comparative study from mixed-type insulin to long-acting insulin analog and GLP-1 recepter agonist.

Region

Japan


Condition

Condition

Type 2 Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare twice daily insulin injection of premixed insulin with combination therapy of Lixisenatide and Glargine for the changes of glycemic variability, blood pressure, feeding behavior in type 2 diabetes mellitus.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Changes of HbA1c, GA and 1.5-AG
Changes of the fasting blood glucose level
Changes of 2 hours postprandial blood glucose level
Achievement of HbA1c less than 7%
Changes of SMBG

Key secondary outcomes

Changes of body weight
Changes of lipids
Changes of the insulin dose
Patient's questionnaire of QOL and feeding behavior
Frequency of hypoglycemia


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Glargine and Lixisenatide 20 microgram

Interventions/Control_2


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

The patients with type 2 diabetes mellitus treated with twice daily insulin injection of premixed insulin
value of HbA1c more than 7.0%
value of BMI more than 22

Key exclusion criteria

Type 1 diabetes mellitus
Subjects who have been experienced severe ketosis, diabetic coma or precoma within 6 months
Subjects in pregnant women, lactating women, the potential or planned are pregnant
Subjects with severe infection, before and just after surgery or severe injury
Subjects treated with adrenocorticosteroid
Subjects with severe hepatic dysfunction
Subjects with impaired insulin secretion
Subjects with a history of pancreatitis or with a pancreatitis
Subjects with a history of a malignant tumor or with a malignant tumor
Subjects who have been determined to be unsuitable for the attending physician

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuyoshi Namba

Organization

Hyogo College Of Medicine

Division name

Division of Diabetes,Endocrinology and Metabolism,Department of Internal Medicine

Zip code


Address

1-1 Mukogawa-cho,Nishinomiya-city,Hyogo,Japan

TEL

0798-45-6111

Email

namba-m@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Fumihiro Ochi

Organization

Hyogo College Of Medicine

Division name

Division of Diabetes,Endocrinology and Metabolism,Department of Internal Medicine

Zip code


Address

1-1 Mukogawa-cho,Nishinomiya-city,Hyogo,Japan

TEL

0798-45-6111

Homepage URL


Email

ochifumi@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College Of Medicine
Division of Diabetes,Endocrinology and Metabolism,Department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2015 Year 02 Month 25 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

Completed

Date of protocol fixation

2014 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 02 Day

Last follow-up date

2017 Year 02 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 25 Day

Last modified on

2017 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019060


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name