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 UMIN000009908
Receipt No. R000011609
Scientific Title In combination therapy with insulin and DPP-4 inhibitor sitagliptin Study of efficacy and safety
Date of disclosure of the study information 2013/01/30
Last modified on 2013/01/30

* 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 In combination therapy with insulin and DPP-4 inhibitor sitagliptin
Study of efficacy and safety
Acronym In combination therapy with insulin and DPP-4 inhibitor sitagliptin
Study of efficacy and safety
Scientific Title In combination therapy with insulin and DPP-4 inhibitor sitagliptin
Study of efficacy and safety
Scientific Title:Acronym In combination therapy with insulin and DPP-4 inhibitor sitagliptin
Study of efficacy and safety
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study the efficacy and safety of sitagliptin added to the administration in patients with type 2 diabetes treated with insulin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes HbA1c
Key secondary outcomes C peptide
Glucagon

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients aged 20 years old or older at the time of obtaining consent

Patients who give written consent of their own free will after receiving a sufficient explanation of the study and fully understanding the study before participation.
Key exclusion criteria Medical history of hypersensitivity to sitagliptin

Age below 20years old at the time of obtaining consent

Judgment of ineligibility to be a subject by the principle investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuko Uchigata
Organization Tokyo Women's Medical University
Division name Diabetes Center
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo,
TEL 03-3353-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Nakagami
Organization Tokyo Women's Medical University
Division name Diabetes Center
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo,
TEL 03-3353-8111
Homepage URL
Email nakagami@dmc.twmu.ac.jp

Sponsor
Institute Diabetes Center,Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Diabetes Center,Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 東京女子医科大学病院(東京都)    Tokyo womens medical university

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 30 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
2011 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 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 Prospective observational study

Management information
Registered date
2013 Year 01 Month 30 Day
Last modified on
2013 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011609

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.