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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007706
Receipt No. R000009086
Scientific Title Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
Date of disclosure of the study information 2012/04/10
Last modified on 2014/10/31

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Basic information
Public title Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
Acronym Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
Scientific Title Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
Scientific Title:Acronym Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
Region
Japan

Condition
Condition Type2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effects of sitagliptin or miglitol combined with insulin therapy on the glycemic control and vascular functions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The blood glucose fluctuations after meal test and vascular endothelial dysfunction
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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 Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
Interventions/Control_2 Research study of sitagliptin and miglitol on type 2 diabetes patients during insulin administration
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with Type 2 diabetes who show postprandial hyperglycemia.
6.5% < HbA1c(JDS) < 8.5%
Key exclusion criteria The exclusion criteria were patients who had taken glinid and sulfonylurea, type 1 diabetes, current history of diabetic ketoacidosis or diabetic come, and/or cerebral stroke, renal insufficiency (serum creatinnin > 1.5 in men, serum creatinin > 1.3 in women, sever infection, current history of operation or trauma, patients with hypersensitive for sitagliptin or miglitol, expectant mother, lactating woman, an age < 20, inappropriate patients judged by the physician in charge
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Takemoto
Organization Chiba University Hospital
Division name Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL 043-222-7171
Email minoru.takemoto@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Takemoto
Organization Chiba University Hospital
Division name Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL 043-222-7171
Homepage URL
Email minoru.takemoto@faculty.chiba-u.jp

Sponsor
Institute Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2012 Year 04 Month 10 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 Open public recruiting
Date of protocol fixation
2012 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2013 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 09 Day
Last modified on
2014 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=R000009086

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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