UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011424 |
|---|---|
| Receipt number | R000013376 |
| Scientific Title | Study of the effect of anagliptin on glucose and lipid metabolism abnormality after the test meal loading. |
| Date of disclosure of the study information | 2013/08/09 |
| Last modified on | 2014/08/16 11:51:38 |
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Basic information
Public title
Study of the effect of anagliptin on glucose and lipid metabolism abnormality after the test meal loading.
Acronym
Study of the effect of anagliptin on glucose and lipid metabolism abnormality after the test meal loading.
Scientific Title
Study of the effect of anagliptin on glucose and lipid metabolism abnormality after the test meal loading.
Scientific Title:Acronym
Study of the effect of anagliptin on glucose and lipid metabolism abnormality after the test meal loading.
Region
| Japan |
Condition
Condition
Impaired glucose tolerance.
Type II diabetes mellitus.
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect and safety of anagliptin on glucose and lipid metabolism after test meal loading in patient with impaired glucose tolerance and/or type II diabetes mellitus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change of TAGE, ApoB48.
Amount of change of iAUC.
Key secondary outcomes
Base
Study type
Interventional
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
SUINY (Anagliptin)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age, gender unquestioned.
2. Patients in need of blood glucose control by DPP-4 inhibitors.
3. Outpatients.
4. Patients who will be able to obtain written informed consent.
Key exclusion criteria
1. Patients who used DPP-4 inhibitors within the last 3 months.
2. Patients with contraindication of anagliptin following:
Patients who have a history of allergy due to anagliptin.
Severe ketosis, diabetic coma or precoma, type I diabetes mellitus.
Severe infection, before and after surgery, patients with severe trauma.
3. Patients on insulin.
4. Patients on rapid-acting insulin secretagogue.
5. Patients with severe renal failure and/or dialysis.
6. Patients with food allergy due to test meal component.
7. Patients who were judged to be inappropriate for the study by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Kobayashi |
Organization
Kanazawa Medical University
Division name
General Internal Medicine
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Kobayashi |
Organization
Kanazawa Medical University
Division name
General Internal Medicine
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
Homepage URL
mary@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
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 | 09 | 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 | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 09 | 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 | 08 | Day |
Last modified on
| 2014 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013376
