UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004689 |
|---|---|
| Receipt number | R000005579 |
| Scientific Title | Effect of DPP-4 inhibitor on beta cell protection |
| Date of disclosure of the study information | 2010/12/09 |
| Last modified on | 2016/02/24 10:55:48 |
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Basic information
Public title
Effect of DPP-4 inhibitor on beta cell protection
Acronym
Effect of DPP-4 inhibitor on beta cell protection
Scientific Title
Effect of DPP-4 inhibitor on beta cell protection
Scientific Title:Acronym
Effect of DPP-4 inhibitor on beta cell protection
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of stagliption as a DPP-4 inhibitor and on beta cell protection (proinsulin/insulin ratio,C-peptide)in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the proinsulin/ insulin ratio after 48 weeks from the baseline
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with type 2 diabetes mellitus who showed insufficient effect with following treatments. They are dietary and exercise therapy alone or those therapies with diabetic medication excluding DPP-4 inhibitors, such as sulfonylureas, thiazolidinediones, biguanides for more than four weeks.
2)Outpatients between 20 and 80 years old.
3)Individuals who could sign informed consent for this trial.
Key exclusion criteria
1)Patients with type 1 diabetes mellitus
2)Patients who developed diabetic ketoacidosis,or diabetic pre-and coma within 24 weeks of the study entry.
3)Patients with severe infections or severe trauma or perioperative state.
4)Patients with renal insufficiency
(CrCl=and>30mL/min, Serum creatinine=and>Male:1.5mg/dl,Female:1.3mg/dl)
5)Patients who received insulin therapy.
6) Patients with severe complication in cardiovascular system within 24 weeks before study entry.
7) Patients with pregnancy, possibility of pregnancy or having a breast feeding.
8)Patients who had a history of hypersensitive reaction to sitagliptin.
9)Patients who are deemed to be inappropriate by the investigator.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suminobu Ito |
Organization
Clinical Research Center,
National Hospital Organization
Division name
Clinical Research Division
Zip code
Address
2-5-23,higasigaoka,Meguro-ku,Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Clinical Research Center,National Hospital Organization
Division name
Clinical trial promotion office,Clinical Research Department
Zip code
Address
TEL
03-5712-5075
Homepage URL
Sponsor or person
Institute
Clinical Research Center,National Hospital Organization
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
| 2010 | Year | 12 | 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
| 2010 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | 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
https://www.nhocrc.jp/dpp4/newpage2.html
Management information
Registered date
| 2010 | Year | 12 | Month | 08 | Day |
Last modified on
| 2016 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005579
