UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002978 |
|---|---|
| Receipt number | R000003614 |
| Scientific Title | The evaluation of insulin secretion pattern on Japanese type 2 diabetes under the usage of DPP-4 inhibitor |
| Date of disclosure of the study information | 2010/01/05 |
| Last modified on | 2017/01/10 16:55:12 |
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Basic information
Public title
The evaluation of insulin secretion pattern on Japanese type 2 diabetes under the usage of DPP-4 inhibitor
Acronym
The evaluation of insulin secretion pattern on Japanese type 2 diabetes under the usage of DPP-4 inhibitor
Scientific Title
The evaluation of insulin secretion pattern on Japanese type 2 diabetes under the usage of DPP-4 inhibitor
Scientific Title:Acronym
The evaluation of insulin secretion pattern on Japanese type 2 diabetes under the usage of DPP-4 inhibitor
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To accurately evaluate insulin secretion, insulin resistance and beta cell function, and examine the effects of DPP-4 inhibitor sitagliptin on Japanese type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Change in glycemic control (1 week after initiation of DPP-4 inhibitor therapy) (FPG, AUC PG during breakfast, 1,5-AG)
Key secondary outcomes
1.Change in insulin secretion (1 week after initiation of DPP-4 inhibitor therapy) (FIRI, Proinsulin/insulin ratio, HOMA-b, AUC IRI during breakfast)
2.Change in insulin sensitivity (1 week after initiation of DPP-4 inhibitor therapy) (HOMA-R)
3.Change in glucagon secretion (1 week after initiation of DPP-4 inhibitor therapy) ( FIRG, AUC IRG during breakfast
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
sitagliptin (50mg/day)
Interventions/Control_2
sitagliptin (50mg/day)
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.capable to be inserted catheters at three different site at both arms
2.capable to drink a bottle of liquid solution that corresponds to 75g glucose
3.capable to take a tablet of DPP-4 inhibitor
Key exclusion criteria
1.Patients with type 2 diabetes used either alpha-glucosidase inhibitors nor any insulin products
2.Patients who had allergy to DPP-4 inhibitor
3.Patients who had insulin allergy
4.type 1 diabetes
5.pancreatic diabetes
6.Patients who had anti-insulin antibodies
7.Serious liver or renal diseases
8.Other conditions precluding participation as judged by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Department of internal medicine, Kobe University Graduate School of medicine
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Department of internal medicine, Kobe University Graduate School of medicine
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5861
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of internal medicine, Kobe University Graduate School of medicine
Division of Diabetes, Metabolism and Endocrinology
Institute
Department
Personal name
Funding Source
Organization
entrusted accounting money
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
| 2010 | Year | 01 | 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
| 2010 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 05 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003614
