UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011369 |
|---|---|
| Receipt number | R000013318 |
| Scientific Title | Efficacy of combination theray of insulin and vildagliptin in Japanese patients with type 2 diabets |
| Date of disclosure of the study information | 2013/08/05 |
| Last modified on | 2019/01/29 12:24:45 |
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Basic information
Public title
Efficacy of combination theray of insulin and vildagliptin in Japanese patients with type 2 diabets
Acronym
insulin and vildagliptin
Scientific Title
Efficacy of combination theray of insulin and vildagliptin in Japanese patients with type 2 diabets
Scientific Title:Acronym
insulin and vildagliptin
Region
| Japan |
Condition
Condition
type 2 diabetic patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify efficacy of combination therapy of insulin and vildagliptin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c, blood glucose, glucagon, c-peptide
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
vildagliptin 50~100mg/day
Interventions/Control_2
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 under insulin therapy whose HbA1c is higher than 6.9%, fasting blood glucose is higher than 129mg/dl or post-prandial glucose is higher than 179mg/dl.
Key exclusion criteria
1. type 1 diabetes or patients with an episode of ketosis
2. anti-GAD anibody(+) or serum CPR is lower than range
3. severe renal failure
4. other uncomfortable state
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiko Yanase |
Organization
Fukuoka university, school of medicine
Division name
Department of endocrinology and diabetes mellitus
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka city, Fukuoka
TEL
092-801-1011
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nomiyama |
Organization
Fukuoka university, school of medicine
Division name
Department of endocrinology ana diabetes mellitus
Zip code
Address
TEL
Homepage URL
tnomiyama@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka university, school of medicine, department of endocrinology and diabetes mellitus
Institute
Department
Personal name
Funding Source
Organization
Fukuoka university, school of medicine, department of endocrinology and diabetes mellitus
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
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
| 2013 | Year | 08 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 05 | 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
| 2013 | Year | 08 | Month | 04 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013318
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
