UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of high dose metformin treatment in patients with type 2 diabetes mellitus
Title of the study (Brief title)	Efficacy of high dose metformin treatment in patients with type 2 diabetes mellitus
Region	Japan

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

Objectives
Narrative objectives1	This study evaluates the difference efficacy and safety between twice-daily taking and thrice-daily taking of high dose metformin in patients with type 2 diabetes mellitus.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Diurnal glycemic profiles
Key secondary outcomes	Continuous Glucose Monitoring Frequency of hyperglycemia Lactate Level

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A: Twice-daily taking in first half part Metformin is increased to 1500mg/day. Twice-daily taking are taken continuous over 4 days in first half part and thrice-daily taking are taken continuous over 4 days in second half part. Diurnal glycemic profiles are evaluated by SMBG(self-monitoring of blood glucose) and CGM(continuous glucose monitoring).
Interventions/Control_2	Group B: thrice-daily taking in first half part Metformin is increased to 1500mg/day. Thrice-daily taking are taken continuous over 4 days in first half part and twice -daily taking are taken continuous over 4 days in second half part. Diurnal glycemic profiles are evaluated by SMBG(self-monitoring of blood glucose) and CGM(continuous glucose monitoring).
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. The patients with type 2 diabetes who are in hospital for glycemic control. 2. Less than 1500mg/day of metformin 3. The patients who have agreed to participate in this study with an informed consent. 4.Age more than 20
Key exclusion criteria	1. Type 1 diabetes 2. Patients contraindicated to metformin 3. Patients judged not to be eligible by the principal investigator
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroshi Ikegami
Organization	Kinki University School of Medicine
Division name	Department of Endocrinology, Metabolism, and Diabetes
Address	377-2 Ohno-Higashi, Osaka-sayama, Osaka, Japan
TEL	+81-72-366-0221(ext.3125)
Email	ikegami@med.kindai.ac.jp

Public contact
Name of contact person	Yoshihisa Hiromine
Organization	Kinki University School of Medicine
Division name	Department of Endocrinology, Metabolism, and Diabetes
Address	377-2 Ohno-Higashi, Osaka-sayama, Osaka, Japan
TEL	+81-72-366-0221(ext.3125)
Homepage URL
Email	hiromine@med.kindai.ac.jp

Sponsor
Institute	Department of Endocrinology, Metabolism, and Diabetes Kinki University School of Medicine
Institute
Department

Funding Source
Organization	None
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	近畿大学医学部附属病院（大阪府

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 05 Day
Anticipated trial start date	2013 Year 06 Month 19 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded	2017 Year 09 Month 30 Day

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

Management information
Registered date	2013 Year 09 Month 02 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013598