UMIN-CTR Clinical Trial

Public title

Clinical Study on rapid-acting insulin analog in intensive basal and bolus insulin therapy ~ Efficacy and safety of glulisine-based multiple daily injection therapy in Japanese diabetic patients

Acronym

Clinical Study on rapid-acting insulin analog in intensive basal and bolus insulin therapy ~ Efficacy and safety of glulisine-based multiple daily injection therapy in Japanese diabetic patients

Scientific Title

Clinical Study on rapid-acting insulin analog in intensive basal and bolus insulin therapy ~ Efficacy and safety of glulisine-based multiple daily injection therapy in Japanese diabetic patients

Scientific Title:Acronym

Clinical Study on rapid-acting insulin analog in intensive basal and bolus insulin therapy ~ Efficacy and safety of glulisine-based multiple daily injection therapy in Japanese diabetic patients

Region

Japan

Condition

Type 1 and type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Study the efficacy and safety of insulin glulisine in diabetes patients who were treated with bolus insulin -Asp, Lisp, was changed to the same unit of glulisine along with diet and exercise.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Efficacy endpoints: Amounts and changing value of blood glucose control markers (HbA1c, blood glucose, glycosylated albumin and 1.5-AG) and diabetic complication markers (urinary albumin excretion ratio, s-RAGE, MCP-1 and TAGE) for each measurement point will be evaluated with descriptive statistics
Safety endpoints: The incident rate and the situation of side effects and adverse events during observation and treating periods. Laboratory evidence is the use of descriptive statistics.

Key secondary outcomes

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

Diabetic patients with &#8805; HbA1c6.2% who were treated with bolus insulin -Asp, Lisp, was changed to the same unit of Gl along with diet and exercise. Basal insulin dosage is basically not changed. They were observed for 24 weeks with caution of hypoglycemic, FPG<120mg/dL, PPG<160mg/dL, and insulin dosage was adjusted with judgment of the consulting doctors

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Type 1 or 2 diabetes patients who were treated with bolus insulin -Asp or Lisp and basal insulin -glargine more than 8 weeks.
2) HbA1c &#8805; 6.2%
3) Over 20 years old
4) Voluntarily signed to the consent form after taking enough explanation of the significance and the objectives of this study

Key exclusion criteria

1) Inability to provide informed consent
2) Patients with sever ketosis, coma diabeticum, pre coma diabeticum in the last 6 months
3) Patients with serious infection, pre/post surgery, or sever external injury
4) Pregnancy or patients with possibility of pregnancy, patients with breath feeding
5) Patients who are not appropriate to participate this investigation judged by the consulting doctor

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Katsuyuki Yanagisawa

Organization

Sapporo City Generarl Hospital

Division name

Department of diabetes and endocrinology

Zip code

Address

Kita11, Nishi13, Chuo-ku, Sapporo, 060-8604, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Sapporo City Generarl Hospital

Division name

Department of diabetes and endocrinology

Zip code

Address

TEL

Homepage URL

Email

kyanagi@med.hokudai.ac.jp

Institute

Sapporo City Generarl Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2013

Year

05

Month

13

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

Completed

Date of protocol fixation

2012

Year

03

Month

31

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

2013

Year

05

Month

13

Day

Last modified on

2013

Year

05

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012508