UMIN-CTR Clinical Trial

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

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Fukuiken Saiseikai Hospital

Institute

Department

Personal name

Organization

no source of funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

08

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

08

Month

29

Day

Last modified on

2020

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008648