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 |
* 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
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
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
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
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
