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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031837
Receipt No. R000036358
Scientific Title Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin: randomised crossover study
Date of disclosure of the study information 2018/03/22
Last modified on 2018/09/21

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Basic information
Public title Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin: randomised crossover study
Acronym Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin
Scientific Title Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin: randomised crossover study
Scientific Title:Acronym Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin
Region
Japan

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

Objectives
Narrative objectives1 To investigate an early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 15% reduction achieving number of days [mean glucose level (24:00)]
Key secondary outcomes 15% reduction achieving time (hour) [mean glucose level (0:00-8:00, every 1 hour)]
15% reduction achieving number of days [mean glucose level (0:00-8:00)]
15% reduction achieving number of days [mean glucose level (8:00-24:00)]
15% reduction achieving number of days [SD (0:00-8:00)]
15% reduction achieving number of days [SD (24:00)]
15% reduction achieving number of days [SD (8:00-24:00)]
Glycemic variability percentage (GVP) from the day before intervention start to 15% reduction achieving

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
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 FreeStyle Libre Pro is attached after admission. Vildagliptin 100 mg are started to use from day3 and dose of metformin increases (500 to 1000 mg) from day5. Then, vildagliptin is washed out and metformin is reduced (1000 to 500 mg). Then, dose of metformin increases (500 to 1000 mg) from day10 and vildagliptin 100 mg are started to use from day12.
Interventions/Control_2 FreeStyle Libre Pro is attached after admission. dose of metformin increases (500 to 1000 mg) from day3 and vildagliptin 100 mg are started to use from day5. Then, vildagliptin is washed out and metformin is reduced (1000 to 500 mg). Then, vildagliptin 100 mg are started to use from day10 and dose of metformin increases (500 to 1000 mg) from day12.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria type 2 diabetic patients medicated metformin 500 mg + basal-bolus insulin therapy of Glargine300+glulisine for 3 month or longer
Key exclusion criteria renal dysfunction (patients whose estimated glomerular filtration rate was less than 45 ml/min/1.73m2)
judged to be unsuitable for participation for medical reasons
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soichi Takeishi
Organization General Inuyama Chuo Hospital
Division name Diabetes
Zip code
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Email souichi19811225@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soichi Takeishi
Organization General Inuyama Chuo Hospital
Division name Diabetes
Zip code
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Homepage URL
Email souichi19811225@yahoo.co.jp

Sponsor
Institute General Inuyama Chuo Hospital
Institute
Department

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
2018 Year 03 Month 22 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
2018 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 22 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
2018 Year 03 Month 22 Day
Last modified on
2018 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036358

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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