UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy
Title of the study (Brief title)	Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy
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 the background characteristics of type 2 diabetes mellitus patients that provide an advantage to switch the additional insulin of intensive insulin therapy after the resolution of glucose toxicity to mitiglinide calcium hydrate tablets or mitiglinide calcium hydrate/voglibose combination tablets. The efficacy of mitiglinide calcium hydrate tablets as well as mitiglinide calcium hydrate/voglibose combination tablets on basal insulin use is also studied.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Mean amplitude of glycemic excursions (MAGE) 2) Mean blood glucose level 3) Standard deviation (SD) of blood glucose level 4) Rate of glucose level AUC>=180 mg/dL, 70 mg/dL<AUC<180 mg/dL, and <70 mg/dL 5) Maximum and minimum blood glucose levels 6) Incidence of symptomatic hypoglycemia 7) Rate of glucose level <70 mg/dL 8) Blood glucose levels 1 and 2 h after every meal 9) Age, duration of diabetes, urinary CPR, 75g oral glucose tolerance test results (blood glucose, blood insulin, and blood CPR levels before the load, and 30 min, 1 hour and 2 hours after the load), glucagon stimulation test results (blood glucose, blood insulin, and blood CPR levels before and after the load), and the daily dose of additional insulin, the daily dose of basal insulin and the daily dose of total insulin at the time of informed consent
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	After receiving mitiglinide for two days, patients receive mitiglinide / voglibose combination tablets for two days.
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) Type 2 diabetes mellitus patients who are receiving intensive insulin therapy 2) Age >=20 years at the time of obtaining consent 3) Hospitalized patients 4) Patients whose glucose toxicity had resolved as judged by the investigator or sub-investigator (e.g., blood glucose level <150 mg/dL at 4 time points throughout a day; namely, before breakfast, before lunch, before dinner, and before going to bed) 5) Patients who are receiving <20 units/day of additional insulin 6) Patients who provided written consent
Key exclusion criteria	1) Patients who are taking other antidiabetes agents than insulin 2) Patients with contraindications against the use of mitiglinide calcium hydrate tablets and mitiglinide calcium hydrate/voglibose combination tablets based on their package inserts 3) Patients who were judged to be ineligible by the investigator or sub-investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Jiro Nakamura
Organization	Aichi Medical University
Division name	Division of Diabetes
Address	1-1 Yazakokarimata Nagakute-shi Aichi-ken
TEL	0561-63-1683
Email	jiro@aichi-med-u.ac.jp

Public contact
Name of contact person	Hideki Kamiya
Organization	Aichi Medical University
Division name	Division of Diabetes
Address	1-1 Yazakokarimata Nagakute-shi Aichi-ken
TEL	0561-63-1683
Homepage URL
Email	hkamiya@aichi-med-u.ac.jp

Sponsor
Institute	Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Kissei Pharmaceutical Co.,LTD.
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	愛知医科大学病院　Aichi Medical University Hospital

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 26 Day
Anticipated trial start date	2015 Year 12 Month 01 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	2015 Year 11 Month 18 Day
Last modified on	2017 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022728