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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016628
Receipt No. 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

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

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
URL(English) https://upload.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


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