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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009690
Receipt No. R000011362
Scientific Title Comparison of incretin-related drugs (GLP-1 receptor agonists and DPP IV inhibitors) and insulin for clinical effects in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2013/01/04
Last modified on 2014/07/12

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Basic information
Public title Comparison of incretin-related drugs (GLP-1 receptor agonists and DPP IV inhibitors) and insulin for clinical effects in patients with type 2 diabetes mellitus
Acronym Comparison of incretin-related drugs (GLP-1 receptor agonists and DPP IV inhibitors) and insulin for clinical effects in patients with type 2 diabetes mellitus
Scientific Title Comparison of incretin-related drugs (GLP-1 receptor agonists and DPP IV inhibitors) and insulin for clinical effects in patients with type 2 diabetes mellitus
Scientific Title:Acronym Comparison of incretin-related drugs (GLP-1 receptor agonists and DPP IV inhibitors) and insulin for clinical effects in patients with type 2 diabetes mellitus
Region
Japan

Condition
Condition type 2 diabetes mellitus
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 therapy of liraglutide, alogliptin and glargine on glycemic control and clinical parameters in patients with type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes change of HbA1c and BW (body mass index)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 liraglutide 0.6-0.9mg/day
Interventions/Control_2 alogliptin 25mg/day
Interventions/Control_3 glargine
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 HbA1c (JDS):7.0-11.0%
Type 2 diabetes
Patients with written informed consent
Key exclusion criteria 1)severe ketosis, diabetic coma within 6 months
2)severe infection, before operation, severe trauma
3)pregnacy
4)liver cirrhosis, chronic renal failure (serum creatinine level>2.0mg/dL), respiratory failure
5)allergy for liraglutide, alogliptin and glargine
6)patients judged by the investigator to be ineligible for some other reason
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenta Okada
Organization Jichi Medical University
Division name Endocrinology and Metabolism
Zip code
Address 3311-1 Yakushiji, Shimotsuke-City, Tochigi, Japan
TEL 0285-44-2111
Email kokada@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenta Okada
Organization Jichi Medical University
Division name Endocrinology and Metabolism
Zip code
Address 3311-1 Yakushiji, Shimotsuke-City, Tochigi, Japan
TEL 0285-44-2111
Homepage URL
Email kokada@jichi.ac.jp

Sponsor
Institute Division of Endocrinology and Metabolism, Jichi Medical University
Institute
Department

Funding Source
Organization Division of Endocrinology and Metabolism, Jichi Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Nasuchuoh hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 B10-88
Org. issuing International ID_1 Jichi Medical University
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 01 Month 04 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
2011 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 29 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 01 Month 04 Day
Last modified on
2014 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011362

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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