UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Vildagriptin versus metformin adding to the inadequate controled type 2 diabetes with multiple daily insulin injection (VMAT)
Title of the study (Brief title)	Vildagriptin versus metformin adding to the type 2 diabetes with multiple daily insulin injection (VMAT)
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For type 2 diabetic paitients controlled inadequately with the Basal-Bolus therapy for more than 3 months, to perform adding whether vildagriptin 100mg or metformin 1500mg .It is intended to be compared the incidence of adverse events such as hypoglycemia and usefulness in glycemic control between the two.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Daily glucose fluctuation (MAGE,SD)
Key secondary outcomes	incidence of hypoglycemia, change of HbA1c,Ratio of bolus inslin and basal insulin

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
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	Adding vildagriptin 100mg to the type 2 diabetes patients with multiple daily injection.
Interventions/Control_2	Adding metformin 1500mg to the type 2 diabetes patients with multiple daily injection.
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	(1)Type 2 diabtes patients who had diagnosed 12 months ago. (2)Patients medicated basal-bolus therapy for more than 12 month (3) Adalts who are 20 years or older (4) Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination
Key exclusion criteria	(1) Type 1 diabetes mellitus patients (2) Patients with severe liver disease (3) Patients with severe renal disease (4) Patients who had myocardial infarction within 3 months, or obvious heart failure case (5) Patients with severe pancreas disease (6) Patients having a cancer (7) Patients with hemoglobin (Hb) less than 11 g/dL (8) Patients that the number of the platelets is less than 100,000 /mm3 (9) Patients with high diabetic neuropathy (10) Patients having a proliferative retinopathy (11) Patients with a serious infectious disease or a serious injury (12) Patients with bowel disease or ileus factors (13) Chronic enteropathy patients with the digestion and absorption abnormality (14) Excessive common custom drinker (15) A pregnant woman or the woman who may be pregnant (16) Patients who was infected with hepatitis B virus or hepatitis C virus (17) In addition, the patient who judged inappropriate by an attendant physician
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroshi Uchino
Organization	Toho University School of Medicine
Division name	Divsion of diabetes, metabolism and endocrinology
Address	6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151
Email	h.uchino@med.toho-u.ac.jp

Public contact
Name of contact person	Hiroshi Uchino
Organization	Toho University School of Medicine
Division name	Divsion of diabetes, metabolism and endocrinology
Address	Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151
Homepage URL
Email	h.uchino@med.toho-u.ac.jp

Sponsor
Institute	Toho University
Institute
Department

Funding Source
Organization	Toho University
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 11 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 10 Month 09 Day
Anticipated trial start date	2014 Year 12 Month 17 Day
Last follow-up date
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	2016 Year 10 Month 31 Day
Last modified on	2016 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028368