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Recruitment status Completed
Unique ID issued by UMIN UMIN000011851
Receipt No. R000013852
Scientific Title The efficacy of vildagliptin on type 2 diabetic patients with basal-bolus insulin therapy in the short-term hospitalization (single-center, randomized, open-label, controlled study).
Date of disclosure of the study information 2013/09/24
Last modified on 2013/09/24

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Basic information
Public title The efficacy of vildagliptin on type 2 diabetic patients with basal-bolus insulin therapy in the short-term hospitalization (single-center, randomized, open-label, controlled study).
Acronym The efficacy of vildagliptin on type 2 diabetic patients with basal-bolus insulin therapy in the short-term hospitalization.
Scientific Title The efficacy of vildagliptin on type 2 diabetic patients with basal-bolus insulin therapy in the short-term hospitalization (single-center, randomized, open-label, controlled study).
Scientific Title:Acronym The efficacy of vildagliptin on type 2 diabetic patients with basal-bolus insulin therapy in the short-term hospitalization.
Region
Japan

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

Objectives
Narrative objectives1 Clarify the efficacy of the administration of vildagliptin on the control of plasma glucose and serum lipid
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The daily profile of plasma glucose and serum lipid at discherge.
Key secondary outcomes the required dose of insulin infusion to maintain the blood glucose normal.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 insulin alone group
From admission, adjust the insulin dose to keep blood glucose of before each meal less than 120mg/dl without vildagliptin administration.
Interventions/Control_2 insulin plus vildagliptin group
From admission, adjust the insulin dose to keep blood glucose of before each meal less than 120mg/dl with vildagliptin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetic patients who were admitted for diabetic control to Nippon Medical School Chiba-Hokusoh hospital
Key exclusion criteria The subjects were excluded, if they were treated with insulin, DPP-4I or GLP-1 receptor agonist, have a history or evidence of liver or endocrine disease, recent myocardial infarction, cerebral vascular disease, heart failure, infectious disease, pregnancy or any carcinoma.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumitaka Okajima
Organization Nippon Medical School, Chiba-Hokusoh Hospital
Division name Division of Endocrinology, Department of Medicine
Zip code
Address 1715 Kamagari, Inzai, Chiba
TEL 0476-99-1111
Email okaji@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumitaka Okajima
Organization Nippon Medical School, Chiba-Hokusoh Hospital
Division name Division of Endocrinology, Department of Medicine
Zip code
Address 1715 Kamagari, Inzai, Chiba
TEL 0476-99-1111
Homepage URL
Email okaji@nms.ac.jp

Sponsor
Institute Nippon Medical School, Chiba-Hokusoh Hospital, Division of Endocrinology, Department of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 日本医大千葉北総病院(千葉県)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 06 Day
Last follow-up date
2013 Year 05 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 24 Day
Last modified on
2013 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013852


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