UMIN-CTR Clinical Trial

Basic information
Public title	the efficiency and safety of rapid acting insulin, glulisine, in the diabetic patients treated with intensive insulin therapy
Acronym	bolus insulin adjust nice control by apidra(BANDRA study)
Scientific Title	the efficiency and safety of rapid acting insulin, glulisine, in the diabetic patients treated with intensive insulin therapy
Scientific Title:Acronym	bolus insulin adjust nice control by apidra(BANDRA study)
Region	Japan

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

Objectives
Narrative objectives1	According to DECODE study1) ,postprandial hyperglycemic events are positively correlated with the frequency of macroangiopathic complications. According to the 2011 IDF guidelines for postprandial blood glucose, PPG should be checked 1-2 hours post meal to prevent vascular complications. The recommend target level is less than 160mg/dl. However, hypoglycemia and weight gain would be a concern if PPG is strictly adjusted by a conventional rapid acting insulin regimen, and that may result in injecting insufficient bolus insulin(4Tstudy2)).Insulin glulisine consists of monomeric and dimeric molecules which leads to rapid onset and short duration after subcutaneous injection and more closely mimics physiologic postprandial insulin action (internal material by Sanofi.Aventis3)). According to a clinical study in Japan, less frequent hypoglycemic events occurred when switching from lispro to the same amount of glulisine (Daikuhara, et al4)).Due to the above reasons, its possible for insulin glulisine to control blood glucose better than conventional rapid acting insulin by suppressing hypoglycemic events without lowering dose.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	1. the diference of HbA1c 2. the diference of GA 3. GA/HbA1c (at 12th week, 24th week) 4. the rate of HbA1c 7.5% acheived
Key secondary outcomes	1. the diference of body weight 2. severe hypoglycemia needed a treatment in hospital 3. DTSQ 4. anyother adverse events and side effects

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	swith from lispro or aspart to glirisine added 1 unit.
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) patient with type 1 or 2 diabetes treated with rpid acting insulin, lipro or aspart for moer than 12 weeks (2) HbA1c(NGSP) 7.5 - 10.5% (3) Duration of diabetes within 10 years (4) Age, 20 - 50 year old (5) Patients who can agree to take part in this study
Key exclusion criteria	-Patients who do not consent to the study. -Patients who have had severe ketosis or who have been in a diabetic coma or precoma within the past 6 months. -Patients who have a severe infection, are in pre/post operation, or have a serious wound. -Patients who are pregnant, lactating or may become pregnant. -Patients who have more than moderate kidney impairment (creatinine clearance is less than 30ml/min.) -Patients judged by their primary physician that they are not appropriate to participate the study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukihiro Bando
Organization	Fukuiken Saiseikai Hospital
Division name	Internal medicine
Zip code
Address	Funahashi Wadanaka 7-1, Fukui, Fukui, Japan
TEL	0776231111
Email	Y-bando@fukui.saiseikai.or.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuo Notsumata
Organization	Fukuiken Saiseikai Hospital
Division name	Internal medicine
Zip code
Address	Funahashi Wadanaka 7-1, Fukui, Fukui, Japan
TEL	0776231111
Homepage URL
Email	Y-bando@fukui.saiseikai.or.jp

Sponsor
Institute	Fukuiken Saiseikai Hospital
Institute
Department

Funding Source
Organization	no source of funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2012 Year 08 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 08 Month 29 Day
Last modified on	2020 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008648

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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