UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of metformin or Metact in type 2 Japnese patients with diabetes
Title of the study (Brief title)	Meatact 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 compare efficacy between 100mg metformin and Metact(500mg metformin+15mg pioglitazone) in Japanese patients with type 2 diabetes who were in indequate blood glucose control with 500mg metformin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cervical IMT, HbA1c, serum adiponectin, serum osteopontin, PWV(pulse wave velocity)
Key secondary outcomes	body weight

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	1000mg metformin
Interventions/Control_2	MetactLD
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Japanese patinets with type 2 diabetes who are in inadequate blood glucose control with 500mg metformin
Key exclusion criteria	allergy for metformin or pioglitazone renal failure type1 diabetes
Target sample size	40

Research contact person
Name of lead principal investigator	Toshihiko Yanase
Organization	Fukuoka university, school of medicine
Division name	Department of Endocrinology and Diabetes Mellitus
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL	092-801-1011
Email

Public contact
Name of contact person	Takashi Nomiyama
Organization	Fukuoka university, school of medicine
Division name	Department of Endocrinology and Diabetes Mellitus
Address
TEL
Homepage URL
Email	tnomiyama@fukuoka-u.ac.jp

Sponsor
Institute	Department of Endocrinology and Diabetes Mellitus, school of medicine, Fukuoka universty
Institute
Department

Funding Source
Organization	Department of Endocrinology and Diabetes Mellitus, school of medicine, Fukuoka universty
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	2013 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 23 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date	2017 Year 09 Month 12 Day
Date of closure to data entry	2017 Year 09 Month 12 Day
Date trial data considered complete	2017 Year 09 Month 12 Day
Date analysis concluded	2017 Year 09 Month 12 Day

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

Management information
Registered date	2012 Year 12 Month 27 Day
Last modified on	2019 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011328