UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011828
Receipt number R000013459
Scientific Title Efficacy and safety of combination therapy of vildagliptin and insulin
Date of disclosure of the study information 2013/09/20
Last modified on 2015/07/08 09:13:16

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Basic information

Public title

Efficacy and safety of combination therapy of vildagliptin and insulin

Acronym

Combination therapy of vildagliptin and insulin

Scientific Title

Efficacy and safety of combination therapy of vildagliptin and insulin

Scientific Title:Acronym

Combination therapy of vildagliptin and insulin

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the safety and efficacy of the combination tharapy of vildagliptin and insulin

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HbA1c

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The administration of vildagliptin

Interventions/Control_2

oral hypoglycemic agent other than vildagliptin

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 with type 2 diabetis mellitus who gave written informed consent to participate in this study.

Patients whose HbA1c is 6.9% or more instead of taking oral hypoglycemic agent(s) in addition to insulin for more than 3 months.

Key exclusion criteria

1. Type 1 diabetes mellitus
2. Ketosis, DM coma or precoma
3. Severe infection, before or after operation, severe trauma
4. Severe liver dysfunction
5. Patients who have allergy to the medicine used in this study
6. preganant or possible pregnant women

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masami Tanaka

Organization

School of Medicine, Keio University

Division name

The department of Internal Medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3797

Email

tana176k@a7.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masami Tanaka

Organization

School of Medicine, Keio University

Division name

Department of Internal Medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3797

Homepage URL


Email

tana176k@a7.keio.jp


Sponsor or person

Institute

Department of Internal Medicine, School of Medicine, Keio University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

2013 Year 09 Month 20 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

2013 Year 06 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 09 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

2013 Year 09 Month 20 Day

Last modified on

2015 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013459


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name