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Recruitment status Completed
Unique ID issued by UMIN UMIN000011828
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute Department of Internal Medicine, School of Medicine, Keio University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013459


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