UMIN-CTR Clinical Trial

Public title

Study of the efficacy and safety of insulin degludec who treating with basal insulin glargine or insulin detemir in type 2 diabetes with the Basal-Bolus Therapy

Acronym

Degludec and Insulin Rapid ExChange study in TOHO for T2D

Scientific Title

Study of the efficacy and safety of insulin degludec who treating with basal insulin glargine or insulin detemir in type 2 diabetes with the Basal-Bolus Therapy

Scientific Title:Acronym

Degludec and Insulin Rapid ExChange study in TOHO for T2D

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

For type 2 diabetic paitients controlled inadequately with the Basal-Bolus therapy for more than 12 months, to perform switching whether once daily morning insulin glargine or insulin degludec.
It is intended to be compared the incidence of adverse events such as hypoglycemia and usefulness in glycemic control between the two.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Daily glucose fluctuation (MAGE,SD), incidence of hypoglycemia, change of QOL,change of HbA1c,Ratio of bolus inslin and basal insulin

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

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

Until December 2015. The basal insulin changes to insulin glargine or insulin degludec. Set to the same dose of the basal insulin before treatment dose of basal insulin. The subcutaneous injection once a morning both groups.

Interventions/Control_2

Insulin aspart and each basal insulin dose is adjusted according to the 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 2 diabtes patients who had diagnosed 12 months ago.
(2)Patients medicated basal-bolus therapy for more than 12 month
(3) Adalts who are 20 years or older
(4) 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) Type 1 diabetes mellitus patients
(2) Patients with severe liver disease
(3) Patients with severe renal disease
(4) Patients who had myocardial infarction within 3 months, or obvious heart failure case
(5) Patients with severe pancreas disease
(6) Patients having a cancer
(7) Patients with hemoglobin (Hb) less than 11 g/dL
(8) Patients that the number of the platelets is less than 100,000 /mm3
(9) Patients with high diabetic neuropathy
(10) Patients having a proliferative retinopathy
(11) Patients with a serious infectious disease or a serious injury
(12) Patients with bowel disease or ileus factors
(13) Chronic enteropathy patients with the digestion and absorption abnormality
(14) Excessive common custom drinker
(15) A pregnant woman or the woman who may be pregnant
(16) Patients who was infected with hepatitis B virus or hepatitis C virus
(17) In addition, the patient who judged inappropriate by an attendant physician

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Ryo Iga

Organization

Toho University School of Medicine

Division name

Division of diabetes, metabolism and endocrinology

Zip code

Address

6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan

TEL

03-3762-4151

Email

ryou.iga@med.toho-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Ryo Iga

Organization

Toho University School of Medicine

Division name

Division of diabetes, metabolism and endocrinology

Zip code

Address

6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan

TEL

03-3762-4151

Homepage URL

Email

ryou.iga@med.toho-u.ac.jp

Institute

Toho University School of Medicine, Division of diabetes, metabolism and endocrinology

Institute

Department

Personal name

Organization

Toho 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

東邦大学医療センター大森病院

Date of disclosure of the study information

2014

Year

11

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

Open public recruiting

Date of protocol fixation

2013

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

11

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

2014

Year

11

Month

29

Day

Last modified on

2014

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014477