UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005769 |
|---|---|
| Receipt number | R000006818 |
| Scientific Title | Usefulness of sitagliptin for type 2 diabetes pacients |
| Date of disclosure of the study information | 2011/06/13 |
| Last modified on | 2011/06/13 15:54:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Usefulness of sitagliptin for type 2 diabetes pacients
Acronym
Usefulness of sitagliptin for type 2 diabetes pacients
Scientific Title
Usefulness of sitagliptin for type 2 diabetes pacients
Scientific Title:Acronym
Usefulness of sitagliptin for type 2 diabetes pacients
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare
1) Achievement rate for glycemic control target,
2) Influence against risk marker for complication of diabetes
3) Influence against an islet of Langerhans function in pancreas
under treatment by sitagliptin in type 2 diabetes patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Achievement rate for glycemic control target
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
Sitagliptin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
type2 diabetes whose HbA1c is 6.5 <= , 20 years-old <=
Key exclusion criteria
1)diabetic ketosis, lethargic sleep
2)infection , past history of abdominal operation, past history of ileus, serious injury
3)pregnancy or suspicious pregnancy, lactation
4)renal failure
5)insulin in use
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Utsunomiya |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461 Japan
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamotsu Yokota |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
Sponsor or person
Institute
Jikei University School of Medicine, Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
NTT Medical Center Tokyo, Showa University,
Toshiba General Hospital, Toho University Omori Medical center, TOHO University Ohashi Medical center, Toranomon Hospital
Name of secondary funder(s)
No
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
| 2011 | Year | 06 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2011 | Year | 06 | Month | 13 | Day |
Last modified on
| 2011 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006818
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
