UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010849 |
|---|---|
| Receipt number | R000012681 |
| Scientific Title | Investigation of efficacy and safety of add-on therapy with DPP-4 inhibitor in type 2 diabetic patients poorly controlled with basal supported oral therapy |
| Date of disclosure of the study information | 2013/05/31 |
| Last modified on | 2015/01/28 11:16:02 |
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Basic information
Public title
Investigation of efficacy and safety of add-on therapy with DPP-4 inhibitor in type 2 diabetic patients poorly controlled with basal supported oral therapy
Acronym
Study of add-on therapy with DPP-4 inhibitor in diabetic patients uncontrolled with BOT
Scientific Title
Investigation of efficacy and safety of add-on therapy with DPP-4 inhibitor in type 2 diabetic patients poorly controlled with basal supported oral therapy
Scientific Title:Acronym
Study of add-on therapy with DPP-4 inhibitor in diabetic patients uncontrolled with BOT
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of add-on therapy with DPP-4 inhibitor in type 2 diabetic patients poorly controlled with BOT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of HbA1c from baseline
Key secondary outcomes
Glucose daily profile by SMBG
Frequency and severity of hypoglycemia
Frequency of other adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
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
patients who take the addition of DPP-4 inhibitor
Interventions/Control_2
patients who do not take the addition of DPP-4 inhibitor
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 diabetic patients with HbA1c(NGSP) 7.0% and more despite the target of fasting glucose level <110mg/dl by titrating insulin
2)Age: 20 to 79 years
3)No concern about the gender
4)Written informed consent are taken for the enrollment
Key exclusion criteria
1)Patients with a history of hypersensitivity to vildagliptin
2)Patients with diabetic ketoacidosis, diabetic coma and type 1 diabetes
3)Patients with severe liver dysfunction
4)Patients with severe infection, perioperative and severe trauma
5)Patients with moderate renal dysfunction or endstage renal disease on hemodialysis
6)Patients with heart failure (NYHA/New York Heart Association stage 3 or severer)
7)Pituitary insufficiency or adrenal insufficiency
8)Patienst with diarrhea, vomiting, starvation and irregular food intake
9)Patients with proliferative diabetic retinopathy
10)Patients who are pregnant, lactating, and possibly pregnant women and those planning to become pregnant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Kanazawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Department of Metabolism & Endocrinology
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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 | 05 | Month | 31 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | 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 | 05 | Month | 31 | Day |
Last modified on
| 2015 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012681
