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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008797
Receipt No. R000008648
Scientific Title the efficiency and safety of rapid acting insulin, glulisine, in the diabetic patients treated with intensive insulin therapy
Date of disclosure of the study information 2012/08/29
Last modified on 2020/03/09

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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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