UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009908
Receipt number 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 18:49:26

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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 or person

Institute

Diabetes Center,Tokyo Women's Medical University

Institute

Department

Personal name



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

Value
https://center6.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