UMIN-CTR Clinical Trial

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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