UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010830
Receipt number R000012682
Scientific Title Trazenta Randomized study for USing insulin patient of Type 2 Diabetes
Date of disclosure of the study information 2013/05/29
Last modified on 2019/03/04 18:20:14

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Basic information

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

Condition

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

Primary outcomes

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

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Japan society for Patient Reported Outcome

Institute

Department

Personal name



Funding Source

Organization

Nippon Boehringer Ingelheim Co, Eli Lilly Japan K.K

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 29 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name