UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trazenta Randomized study for USing insulin patient of Type 2 Diabetes
Title of the study (Brief title)	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	Jun-ichiro Miyagawa
Organization	Hyogo College of Medicine
Division name	Department of Internal Medicine, Division of Diabetes and Metabolism
Address	Mukogawa1-1,Nishinomiya City, Hyogo Prefecture,Japan
TEL	0798-45-6592
Email	miyagawa@hyo-med.ac.jp

Public contact
Name of contact person	takayama Hiroki
Organization	Soiken Inc.
Division name	Division of Clinical Study Support
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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