UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Mitsuyoshi Namba
Organization	Hyogo College Of Medicine
Division name	Division of Diabetes,Endocrinology and Metabolism,Department of Internal Medicine
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	Fumihiro Ochi
Organization	Hyogo College Of Medicine
Division name	Division of Diabetes,Endocrinology and Metabolism,Department of Internal Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019060