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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024663
Receipt No. R000028368
Scientific Title Vildagriptin versus metformin adding to the inadequate controled type 2 diabetes with multiple daily insulin injection (VMAT)
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/31

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Basic information
Public title Vildagriptin versus metformin adding to the inadequate controled type 2 diabetes with multiple daily insulin injection (VMAT)
Acronym Vildagriptin versus metformin adding to the type 2 diabetes with multiple daily insulin injection (VMAT)
Scientific Title Vildagriptin versus metformin adding to the inadequate controled type 2 diabetes with multiple daily insulin injection (VMAT)
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Uchino
Organization Toho University School of Medicine
Division name Divsion of diabetes, metabolism and endocrinology
Zip code
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
1st name
Middle name
Last name Hiroshi Uchino
Organization Toho University School of Medicine
Division name Divsion of diabetes, metabolism and endocrinology
Zip code
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)

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
2016 Year 11 Month 01 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 No longer recruiting
Date of protocol fixation
2014 Year 10 Month 09 Day
Date of IRB
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

Other
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

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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