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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011369
Receipt No. R000013318
Scientific Title Efficacy of combination theray of insulin and vildagliptin in Japanese patients with type 2 diabets
Date of disclosure of the study information 2013/08/05
Last modified on 2019/01/29

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Basic information
Public title Efficacy of combination theray of insulin and vildagliptin in Japanese patients with type 2 diabets
Acronym insulin and vildagliptin
Scientific Title Efficacy of combination theray of insulin and vildagliptin in Japanese patients with type 2 diabets
Scientific Title:Acronym insulin and vildagliptin
Region
Japan

Condition
Condition type 2 diabetic patients
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify efficacy of combination therapy of insulin and vildagliptin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c, blood glucose, glucagon, c-peptide
Key secondary outcomes

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 vildagliptin 50~100mg/day
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
75 years-old >=
Gender Male and Female
Key inclusion criteria type 2 diabetic patients under insulin therapy whose HbA1c is higher than 6.9%, fasting blood glucose is higher than 129mg/dl or post-prandial glucose is higher than 179mg/dl.
Key exclusion criteria 1. type 1 diabetes or patients with an episode of ketosis
2. anti-GAD anibody(+) or serum CPR is lower than range
3. severe renal failure
4. other uncomfortable state
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiko Yanase
Organization Fukuoka university, school of medicine
Division name Department of endocrinology and diabetes mellitus
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka city, Fukuoka
TEL 092-801-1011
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nomiyama
Organization Fukuoka university, school of medicine
Division name Department of endocrinology ana diabetes mellitus
Zip code
Address
TEL
Homepage URL
Email tnomiyama@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka university, school of medicine, department of endocrinology and diabetes mellitus
Institute
Department

Funding Source
Organization Fukuoka university, school of medicine, department of endocrinology and diabetes mellitus
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 08 Month 05 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 Terminated
Date of protocol fixation
2013 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 05 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 08 Month 04 Day
Last modified on
2019 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013318

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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