UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Clinical Comparison of Antidiabetic Agents Treating Postprandial Hyperglycemia, between Repaglinide alone and Mitiglide/Voglibose Fixed-dose Combination using Continuous Glucose Monitoring on Postprandial Profiles.
Title of the study (Brief title)	The comparison between glinides and glinides/aGI combination therapy using CGM
Region	Japan

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

Objectives
Narrative objectives1	After admission,all patients had post prandial hyperglycemia. glycemic levels were monitored for7 consecutive days using CGM (ipro2; Medtronic MiniMedInc., Northridge, CA).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total area under the curve (AUC) within 2 h after each meal, and postprandial glucose levels within 2 h after each meals using 24-h glycemic data from CGM
Key secondary outcomes	we evaluated 24-h mean glucose levels,the mean of the daily difference, mean amplitude of glycemic excursions,rates of proportions of appropriate glucose levels, hyperglycemia, andhypoglycemia

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	Glycemic levels were monitored for 7 consecutive days using CGM (ipro2; Medtronic MiniMed Inc., Northridge, CA).During the study period, the dose ofinsulin and other antidiabetic drugs were fixed.The patients were divided three arms. After starting glucose monitoring, 1) The patients took repaglinide 0.5g three times daily immediately before each meals for two consecutive days, after that miti10mg/Vog0.2mg three times before each meal for two days,the last two days, kept conventional treatment.
Interventions/Control_2	After starting glucose monitoring, 2) The patients kept conventional treatment for two days, after that took repaglinide 0.5mg three times daily immediately before each meals for two consecutive days,the last two days, took miti10mg/Vog0.2mg three times daily immediately before each meals.
Interventions/Control_3	After starting glucose monitoring, 3) The patients took miti10mg/Vog0.2mg three times daily immediately before each meals.kept conventional treatment for two consecutive days, after that, kept conventional treatment for two days,the last two days, took repaglinide 0.5mg three times daily immediately before each meals.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Type 2 diabetes in patient 2)Postprandial glucose levels > 180mg/dl 3)HbA1c values at admition between 7.0 and 13.5% 4)Patients who gave written informed consent
Key exclusion criteria	1)Patients who have severe diabeticketosis, diabetic coma 2)Patients with severe infections, severe injury or perioperative state. 3)Female patients who have pregnancy or possibilty of pregnancy, or are under lactation 4)Patients who had past history of hypersensitivity or allergic reaction to insulin degludec, aspart or liraglutide 5)Patients with severe liver or renal dysfunction.
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshimasa Aso
Organization	Dokkyo Medical University
Division name	Endocrinology and Metabolism
Address	880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL	0282-86-1111
Email	yaso@dokkyomed.ac.jp

Public contact
Name of contact person	Takafumi Niitani
Organization	Dokkyo Medical University
Division name	Endocrinology and Metabolism
Address	880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL	0282-86-1111
Homepage URL
Email	niinii@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
Organization
Division
Category of Funding Organization	Other
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	2016 Year 12 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 29 Day
Anticipated trial start date	2016 Year 12 Month 06 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	2016 Year 12 Month 12 Day
Last modified on	2018 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029022