UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Which is the most compatible combination of oral hypoglycemic agents that incretin action are considered used together with basal insulin? Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study
Title of the study (Brief title)	Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study
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 which is the most compatible combination of oral hypoglycemic agents that incretin action are considered used together with basal insulin, Vildagliptin 100 mg +Metformin 500 mg, Vildagliptin 100 mg +Miglitol 150 mg or Metformin 500 mg+Miglitol 150 mg.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	24h glycemic variability percentage (GVP)
Key secondary outcomes	24h percentage of time in target range (70~140 mg/dL) 24h mean absolute glucose (MAG) mean glucose level (24h, 00:00~06:00, 08:00~24:00) standard deviation (SD)(24h, 00:00~06:00, 08:00~24:00) coefficient of variation (CV)(24h, 00:00~06:00, 08:00~24:00) MAGE MODD ADRR HIgh blood glucose index (HBGI) Highest postprandial glucose level within 3 hours after each meal AOC (<70 mg/dL) for glycemic variability (24h)

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	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	FreeStyle Libre Pro is worn after admission. Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 3 and day 4. Then, Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 8 and day 9. Then, Metformin 500 mg+Miglitol 150 mg are evaluated on day 13 and day 14.
Interventions/Control_2	FreeStyle Libre Pro is worn after admission. Metformin 500 mg+Miglitol 150 mg are evaluated on day 3 and day 4. Then, Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 8 and day 9. Then, Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 13 and day 14.
Interventions/Control_3	FreeStyle Libre Pro is worn after admission. Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 3 and day 4. Then, Metformin 500 mg+Miglitol 150 mg are evaluated on day 8 and day 9. Then, Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 13 and day 14.
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 with insulin glargine 300 U/ml for 3 month or longer
Key exclusion criteria	severe renal dysfunction (eGFR less than 45) 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	Self funding
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 09 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 04 Day
Anticipated trial start date	2017 Year 09 Month 04 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 09 Month 04 Day
Last modified on	2018 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033168