UMIN-CTR Clinical Trial

Public title

Trazenta Randomized study for USing insulin patient of Type 2 Diabetes

Acronym

TRUST2

Scientific Title

Trazenta Randomized study for USing insulin patient of Type 2 Diabetes

Scientific Title:Acronym

TRUST2

Region

Japan

Condition

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess efficacy, safety, and influence of the combination drug therapy, Linagliptin and Insulin, for the improvement of glycemic control and diabetic symptom with comparing Group A, patients who take Linagliptin as DPP-4, and Group B, patients who do not take Linagliptin.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Assessment of efficacy to glycemic control from baseline (Visit 0) to 16 weeks.
Quantity change of HbA1c

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

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

Group A; patients who take the addition of Linagliptin

Interventions/Control_2

Group B; patients who do not take the addition of Linagliptin

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

1.Patients with only one type insulin,or with the combination drug therapy of oral diabetic medicine,except DPP4 inhibitor and Alpha-GI more than 3 months.
Also, patients who had not taken Incretin Formula, such as DPP-4 inhibitor, more than 12 weeks can enroll this study. No concern about the number of insulin shot per day.
2.Type 2 diabetic patients (HbA1c(NGSP value),higher than 7.0% but lower than 10.0%)
3.age,20-80
4.Written informed consent are taken for the enrollment

Key exclusion criteria

Person who correspond to any of following are excluded:
1.Patients who are Type I or Secondary diabetic mellitus
2.Patients who are treating with Insulin, more than 1 I.U/kg per day
3.Patients who are treating with two or more types of Insulin
4.Patients who are treating with CSII (Continuous Subcutaneous Insulin Infusion)
5.Patients who are treating with DPP-4 Inhibitor, GLP-1 and Alpha-GI at the time of study initiation
6.Patients who are severe infectious disease, perioperative, and severe trauma
7.Patients with myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction
8.Patients with severe liver dysfunction ( AST:100 IU/l or higher)
9.Patients with moderate or severer heart failure (NYHA/New York Heart Association stage 3 or severer)
10.Patients who require dialysis.
11.Patients who are pregnant, lactating, and possibly pregnant women and those planning to become pregnant
12.Patients with a history of hypersensitivity to investigational drugs.
13.Patients with cancer
14.Patients who receive steroid therapy with inflammatory affection
15.Patients whom doctor judges as ineligible to this study

Target sample size

244

Name of lead principal investigator

1st name
Middle name
Last name	Jun-ichiro Miyagawa

Organization

Hyogo College of Medicine

Division name

Department of Internal Medicine, Division of Diabetes and Metabolism

Zip code

Address

Mukogawa1-1,Nishinomiya City, Hyogo Prefecture,Japan

TEL

0798-45-6592

Email

miyagawa@hyo-med.ac.jp

Name of contact person

1st name
Middle name
Last name	takayama Hiroki

Organization

Soiken Inc.

Division name

Division of Clinical Study Support

Zip code

Address

1-4-2, Shin-Senri Higashimachi, Toyonaka, Osaka

TEL

03-3295-1350

Homepage URL

Email

takayama@soiken.com

Institute

Japan society for Patient Reported Outcome

Institute

Department

Personal name

Organization

Nippon Boehringer Ingelheim Co, Eli Lilly Japan K.K

Organization

Division

Category of Funding Organization

Profit organization

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

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

Completed

Date of protocol fixation

2013

Year

04

Month

15

Day

Date of IRB

Anticipated trial start date

2013

Year

06

Month

03

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

29

Day

Last modified on

2019

Year

03

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012682