UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004689
Receipt No. 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

* 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 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
Email

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
Email

Sponsor
Institute Clinical Research Center,National Hospital Organization
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005579

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.