UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy).
Title of the study (Brief title)	Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy).
Region	Japan

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

Objectives
Narrative objectives1	Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of time with in the predefined FGM glucose range of 70-179mg/dl(normal range).
Key secondary outcomes	Percentage of time with in the predefined FGM glucose range of >180mg/dl (hyperglycemia range) <70mg/dl(hypoglycemia range) <54mg/dl(severe hypoglycemia range) Nocturnal hypoglycemia(0:00-5:59) mean glucose level,SD-value,CV-value,Mean Amplitude of Glycemic Excursions,M-value,MODD

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	Deguldec/Aspart is administered twice in the morning and evening, and the dosage is adjusted to fix the unit going to pre-breakfast and pre-dinner with the goal of 100-130mg/dl. FGM (Flash Glucose Monitoring) is attached and the blood glucose level on the 2-4days is evaluated. FGM (Flash Glucose Monitoring) is attached and the blood glucose level on the 2-4days is evaluated. Switching 80% of basal dose of degludec/aspart to glarginU300 morning dose, switching same dose of bolus to glulisine evening, 2-h postprandial blood glucose adjust glulisine to target less than 180mg/dl blood glucose (5-6days). Increase the basal amount of degludec/aspart at the time of switching glargine U300. 2-h postprandial blood glucose adjust glulisine to target less than 180 mg/dl blood glucose (7-12days) Evaluate blood glucose level on 12-14days
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Diabetic patients who are needed to glycemic contro
Key exclusion criteria	1.Serious ketosis, history of diabetic coma or precoma 2.Pregnancy or lactation and patients scheduled 3.Serious infection, trauma, undergo surgery 4.Receiving steroid therapy. 5.Severe liver dysfunction 6.Type 1 diabetes 7.Hypersensitivity to degludec/aspart, glargin, glulisine. 8.History of malignancy or malignancy. 9.Judged to be unsuitable for participation for medical reasons.
Target sample size	20

Research contact person
Name of lead principal investigator	Yuji Kawaguchi
Organization	Minami Osaka hospital
Division name	Internal medicine
Address	1-18-18,higashikagaya,suminoe-ku,Osaka,559-0012,Japan
TEL	06-6685-0221
Email	y.kawaguchi@minamiosaka.com

Public contact
Name of contact person	Yuji Kawaguchi
Organization	Minami Osaka hospital
Division name	Internal medicine
Address	1-18-18,higashikagaya,suminoe-ku,Osaka,559-0012,Japan
TEL	06-6685-0221
Homepage URL
Email	y.kawaguchi@minamiosaka.com

Sponsor
Institute	Minami Osaka hospital
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	南大阪病院(大阪府)

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 24 Day
Anticipated trial start date	2018 Year 01 Month 04 Day
Last follow-up date	2018 Year 11 Month 30 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 02 Month 28 Day
Date analysis concluded	2019 Year 03 Month 31 Day

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

Management information
Registered date	2017 Year 12 Month 30 Day
Last modified on	2018 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034993