UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011851 |
|---|---|
| Receipt number | 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 16:38:29 |
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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.
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
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
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
okaji@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School, Chiba-Hokusoh Hospital, Division of Endocrinology, Department of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013852
