UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of titration method in basal insulin therapy using Vildagliptin 100 mg +Metformin 500 mg: randomised crossover study
Title of the study (Brief title)	Investigation of titration method in basal insulin therapy using Vildagliptin 100 mg +Metformin 500 mg
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 100 mg+Metformin 500 mg in basal insulin therapy titration
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 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. Metformin 500 mg are started to use from day3 and dose of Glargine300 increases from day5. Then, dose of Glargine300 increases from day10 and Metformin 500 mg are started to use from day12.
Interventions/Control_2	FreeStyle Libre Pro is attached after admission. dose of Glargine300 increases from day3 and Metformin 500 mg are started to use from day5. Then, Metformin 500 mg are started to use from day10 and dose of Glargine300 increases 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 Vildagliptin 100 mg+Glargine300 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	Soichi Takeishi
Organization	General Inuyama Chuo Hospital
Division name	Department of Diabetes
Address	6, Futagozuka, Goromaru, Inuyama-city, Aichi, 484-8511, Japan.
TEL	0568-62-8111
Email	souichi19811225@yahoo.co.jp

Public contact
Name of contact person	Soichi Takeishi
Organization	General Inuyama Chuo Hospital
Division name	Department of Diabetes
Address	6, Futagozuka, Goromaru, Inuyama-city, Aichi, 484-8511, Japan.
TEL	0568-62-8111
Homepage URL
Email	souichi19811225@yahoo.co.jp

Sponsor
Institute	General Inuyama Chuo Hospital
Institute
Department

Funding Source
Organization	General Inuyama Chuo Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 11 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 08 Day
Anticipated trial start date	2017 Year 11 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 08 Day
Last modified on	2018 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034133