UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010830
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Japan society for Patient Reported Outcome
Institute
Department

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
URL(English) https://upload.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


Contact us.