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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016966
Receipt No. R000017090
Scientific Title Study of the clinical utility and safety in combination use of the GLI-1 analogue and Insulin degludec in type 2 diabetic patients.
Date of disclosure of the study information 2015/03/30
Last modified on 2015/07/22

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Basic information
Public title Study of the clinical utility and safety in combination use of the GLI-1 analogue and Insulin degludec in type 2 diabetic patients.
Acronym Study of the clinical utility and safety in combination use of the GLI-1 analogue and Insulin degludec in type 2 diabetic patients.
Scientific Title Study of the clinical utility and safety in combination use of the GLI-1 analogue and Insulin degludec in type 2 diabetic patients.
Scientific Title:Acronym Study of the clinical utility and safety in combination use of the GLI-1 analogue and Insulin degludec in type 2 diabetic patients.
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to assess the effect of combination therapy of liraglutide and insulin degludec on glycemic control and safety in patients with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes change of HbA1c
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Despite while using liraglutide , deterioration in glycemic control , or administered to a patient in weight gain.
Interventions/Control_2
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 written IC.
2)Patients who use Liraglutide of Deterioration.
3)HbA1c (NGSP):more than 6.2%.
Key exclusion criteria 1)Patients with advanced diabetic complications.
2)Patients with to the contraindication of GLP-1 receptor agonist (Victoza subcutaneous injection18mg) (Liraglutide)
3)Patients with to the contraindication of the long acting insulin analog formulation (Tresiba Injection) (Degludec)
4)Patients judged by the investigator to be ineligible for some other reason
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Toyoda
Organization Department of Internal Medicine, Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL 0563-93-1121
Email m-toyoda@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wakana Miura
Organization Department of Internal Medicine, Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL 0563-93-1121
Homepage URL
Email happy0897@gmail.com

Sponsor
Institute Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Institute
Department

Funding Source
Organization Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 03 Month 30 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 06 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 07 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
2015 Year 03 Month 30 Day
Last modified on
2015 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017090

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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