UMIN-CTR Clinical Trial

Public title

The efficacy and the safety of the new long-acting insulin in patient with diabetes

Acronym

The efficacy and the safety of the new long-acting insulin in patient with diabetes

Scientific Title

The efficacy and the safety of the new long-acting insulin in patient with diabetes

Scientific Title:Acronym

The efficacy and the safety of the new long-acting insulin in patient with diabetes

Region

Japan

Condition

diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare an new long-acting insulin with existing diabetes therapeutic drug for efficacy and safety in diabetes

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in HbA1c, the body weight, the custom-built diabetes treatment satisfaction questionnaire result and adverse events including hypoglycemia at 24weeks later from an examination start

Key secondary outcomes

From an examination start, it is the following items 24 weeks later
-Achievement rate of HbA1c<7.0% and<8.0%
-Change in fasting blood glucose
-Glycemic variability by SMBG
-Change in insulin dose(daily basal insulin doses, daily total insulin doses)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

concentrated preparation of insulin glargine
The dosing period is from start of examination to implementation of the questionnaire 3~6 months after.We set the dose to the target of less than HbA1c7%.The patients take blood test and examination every 1~2 months.

Interventions/Control_2

insulin degludec including the premixed insulin preparations
The dosing period is from start of examination to implementation of the questionnaire 3~6 months after.We set the dose to the target of less than HbA1c7%.The patients take blood test and examination every 1~2 months.

Interventions/Control_3

Continuing with the treatment so far
The dosing period is from start of examination to implementation of the questionnaire 3~6 months after.We set the dose to the target of less than HbA1c7%.The patients take blood test and examination every 1~2 months.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients whose HbA1c are more than 8.0% or who are already using insulin

Key exclusion criteria

Contraindicated patient in the attached document of the insulin preparations
Contraindicated patient in the attached document of diabetes drugs
Hypoglycemic risk
Serious heart trouble
Severe hepatic dysfunction
Severe renal dysfunction
Internal secretion disease
Needs the steroid dosage
Patients judged by the investigator to be ineligible for some other reason

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Koichiro Yasuda

Organization

Osaka Saiseikai Noe Hospital

Division name

Department of Diabetes and Endocrinology

Zip code

Address

1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan

TEL

06-6932-0401

Email

kyasuda@noe.saiseikai.or.jp

Name of contact person

1st name
Middle name
Last name	Mitsuru Ota

Organization

Osaka Saiseikai Noe Hospital

Division name

Department of Diabetes and Endocrinology

Zip code

Address

1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan

TEL

06-6932-0401

Homepage URL

Email

mitsuru.ota@noe.saiseikai.or.jp

Institute

Osaka Saiseikai Noe Hospital

Institute

Department

Personal name

Organization

Osaka Saiseikai Noe Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

None

Name of secondary funder(s)

None

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

大阪府済生会野江病院(大阪府)/Osaka Saiseikai Noe Hospital (Osaka)

Date of disclosure of the study information

2016

Year

01

Month

11

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

2016

Year

01

Month

11

Day

Date of IRB

2016

Year

01

Month

11

Day

Anticipated trial start date

2016

Year

01

Month

11

Day

Last follow-up date

2018

Year

01

Month

11

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

01

Month

11

Day

Last modified on

2019

Year

07

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023691