UMIN-CTR Clinical Trial

Public title

Insulin degludec compared with conventional basal insulin in basal-bolus therapy with type 1 and type2 diabetes in outpatient: A 24-week, randomized, open-label, treat-to-target trial

Acronym

Showa university Examines the Effects of Insulin Degludec

Scientific Title

Insulin degludec compared with conventional basal insulin in basal-bolus therapy with type 1 and type2 diabetes in outpatient: A 24-week, randomized, open-label, treat-to-target trial

Scientific Title:Acronym

Showa university Examines the Effects of Insulin Degludec

Region

Japan

Condition

Type 1 and Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare glucose lowering effect of insulin degludec to conventional basal insulin analogue in Japanese patient with type 1 and type 2 diabetes in basal-bolus treatment

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The change in HbA1c after 16weeks of treatment from baseline

Key secondary outcomes

Hypoglycemic episodes
Change in fasting glucose levels
6-points SMBG profiles
DTSQs scale score
The change in HbA1c after 24weeks of treatment from baseline

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

.Insulin degludec(24weeks)

.Initial insulin doses were replased with insulin degludec or conventional basal insulin in a 1:1 ratio(enable the basal insulin dose decrease by the judgment of the investigator)

.The subjects come to the hospital once a month for the duration of treatment and regulate insulin dose based on administration algorithm by the self monitoring of blood glucose(SMBG) level

.Bolus insulin dose adjustment is not given a dose adjustment after administration as much as possible until 16 weeks.(16 weeks later, we allowed to regulate a dose based on administration algorithm)

Interventions/Control_2

.Long-acting insulin analogue other than insulin degludec(24weeks)

.Initial basal insulin doses were replased with insulin degludec or conventional basal insulin in a 1:1 ratio(enable the basal insulin dose decrease by the judgment of the investigator)

.The subjects come to the hospital once a month for the duration of treatment and regulate insulin dose based on administration algorithm by the self monitoring of blood glucose(SMBG) level

.Bolus insulin dose adjustment is not given a dose adjustment after administration as much as possible until 16 weeks.(16 weeks later, we allowed to regulate a dose based on administration algorithm)

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 and Type 2 diabetes receiving Basal-bolus insulin therapy in outpatient

2.All subjects had been treated with basal-bolus insulin therapy for>4 months prior to trial acreening

3.In the case of type 1 diabetes, a duration of a disease is more than 12 months

4.The patients who are available for self monitoring of blood glucose

5.Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination

Key exclusion criteria

1.Patients with a history of hypersensitivity to insulin

2.Patients with severe ketosis, diabetic coma or the former comatose

3.Patients with severe renal dysfunction including the patients needing haemodialysis or peritoneal dialysis

4.Patients with the pre or proliferative retinopathy,including in the vitreous haemorrhage risk.

5.Patients with the serious infection, the perioperative period and the serious trauma

6.Patients with the pregnant woman or the woman who may be pregnant

7.In addition, the patient who judged inappropriate by an attendant physician

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Tomoyasu Fukui

Organization

Showa University School of Medicine

Division name

Department of Medicine, Division of Diabetes, Metabolism and Endocrinology

Zip code

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo,Japan

TEL

03-3784-8000

Email

showauft@med.showa-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomoyasu Fukui

Organization

Showa University School of Medicine

Division name

Department of Medicine, Division of Diabetes, Metabolism and Endocrinology

Zip code

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo,Japan

TEL

03-3784-8000

Homepage URL

Email

showauft@med.showa-u.ac.jp

Institute

Showa University School of Medicine
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology

Institute

Department

Personal name

Organization

Showa University School of Medicine

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

2016

Year

03

Month

01

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

2013

Year

04

Month

25

Day

Date of IRB

Anticipated trial start date

2013

Year

08

Month

10

Day

Last follow-up date

2015

Year

02

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

02

Month

16

Day

Last modified on

2016

Year

02

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024284