UMIN-CTR Clinical Trial

Public title

Effects of Insulin Degludec versus Insulin Glargine in basal-bolus treatment in type 2 diabetes assessed by continuous glucose monitoring system

Acronym

JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study

Scientific Title

Effects of Insulin Degludec versus Insulin Glargine in basal-bolus treatment in type 2 diabetes assessed by continuous glucose monitoring system

Scientific Title:Acronym

JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study

Region

Japan

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare insulin degludec with insulin glargine for efficacy and safety in type 2 diabetic patients with basal-bolus insulin therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Comparison of blood glucose variability of the two treatments (insulin degludec as basal insulin vs insulin glargin) by the Continuous Glucose Monitoring System (CGMS®, Medtronic MiniMed, Inc.)

Key secondary outcomes

The difference between treatments in following parameters: fasting plasma glucose (FPG), variability (standard deviation) and intra individual variability of 7-point capillary blood glucose profile value measured by SMBG, frequency and severity of hypoglycemic episodes (confirmed by blood glucose < 70 mg/dl) .

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

Insulin glargine is replaced to insulin degludec with same insulin dose under the treatment of basal-bolus insulin therapy in type 2 diabetes.

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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

Hospitalized patients with type 2 diabetes with Basal-Bolus therapy using insulin glargine

(1)subjcets whose fasting blood glucose are controlled to less than 140 mg/dl

(2)subjcets whose age are more than 20 years and under 80 years.

(3)no restriction on gender

(4)written informed consent was obtained from all subjects after they had been provided with sufficient information
about the study.

Key exclusion criteria

1.Patients with past medical history of hypersensitivity to Degludec.
2.Patients with serious liver,renal,pituitary and adrenal insufficiency.
3.Patients with diarrhea, vomiting and other gastrointestinal problems.
4.Patients with starvation state or unstable appetite.
5.Patients with serious diabetic complications including proliferative retinopathy.
6.Patients who are pregnant, hope to be pregnant, or are in lactation period.
7.Judged as ineligible by clinical investigators
8.Patients with type 1 diabetes

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	hiromasa goto

Organization

Juntendo University Graduate School of Medicine

Division name

Dept. of Metabolism and Endocrinology

Zip code

Address

2-1-1 Hongo Bunkyo-ku Tokyo JAPAN

TEL

03-3813-3111

Email

gokky@juntendo.ac.jp

Name of contact person

1st name
Middle name
Last name	Megumi Hada

Organization

Juntendo University Graduate School of Medicine

Division name

Dept. of Metabolism and Endocrinology

Zip code

Address

2-1-1 Hongo Bunkyo-ku Tokyo JAPAN

TEL

03-3813-3111

Homepage URL

Email

blessing_toy_113@yahoo.co.jp

Institute

Juntendo University Graduate School of Medicine

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

04

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

02

Month

19

Day

Date of IRB

Anticipated trial start date

2013

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

03

Month

14

Day

Last modified on

2015

Year

03

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011824