UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of oral hypoglycemic agent for postprandial hyperglycemia administered two times daily on glycemic control in patients with type 2 diabetes with Mitiglinide / Voglibose combination tablets
Title of the study (Brief title)	Effect of twice daily administration on glycemic control in patients with type 2 diabetes with Mitiglinide / Voglibose combination tablets.
Region	Japan

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

Objectives
Narrative objectives1	Effect of oral hypoglycemic agent for postprandial hyperglycemia administered two times daily on glycemic control in patients with type 2 diabetes with Mitiglinide / Voglibose combination tablets
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	HbA1c Comparison at16weeks,24 weeks from the start of administration
Key secondary outcomes	GA 1.5AG Fasting blood glucose Fasting insulin HOMA-R Serum CPR

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Mitiglinide calcium hydrate administration group
Interventions/Control_2
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)Patients are being treated with diet therapy and DPP-4 inhibitor, metformin for more than 8 weeks (56 days) prior to the start of the study. 2)HbA1c (NGSP) before clinical trial start is 7.0% or more and 9.0% or less. 3)Patients are not clinically problematic anemia. 4)over 20 years age 5)Out patient 6)Patients who provided written consent
Key exclusion criteria	1) Patients with contraindications against the use of mitiglinide calcium hydrate tablets and mitiglinide calcium hydrate/voglibose combimation tablets based on their package inserts. 2) Patients who had taken sulfonylureas, GLP-1 receptor agonists,glinide,a-GI, SGLT-2 inhibitors, insulin within 8 weeks (56 days) before the start of the study 3) Excessive drinkers 4) Patients with severe diabetic microangiopathy 5) Patients with severe liver / kidney function decline 6) Patients with severe heart disease 7) Patients with severe hypertension combined 8) Patients with open surgery or previous bowel obstruction 9)Patients who were judged to be ineligible to be ineligible by the investigator or sub-investigator
Target sample size	50

Research contact person
Name of lead principal investigator	Yasushi Tanaka
Organization	St.Marianna University School of Medicine
Division name	Division of Endocrinology and Metabolism
Address	2-16-1
TEL	044-977-8111
Email	y2tanaka@marianna-u.ac.jp

Public contact
Name of contact person	Hiroyuki Kato
Organization	St.Marianna University School of Medicine Hospital
Division name	Division of Endocrinology and Metabolism
Address	2-16-1 Sugou, Miyamae-ku Kawasaki-city Kanagawa-ken
TEL	044-977-8111
Homepage URL
Email	h.k.kato@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Kissei Pharmaceutical Co
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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 02 Month 17 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 05 Month 31 Day
Anticipated trial start date	2016 Year 05 Month 31 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 02 Month 17 Day
Last modified on	2018 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021729