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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010998
Receipt No. R000012872
Scientific Title Comparison between the clinical efficacy of linagliptin and sitagliptin
Date of disclosure of the study information 2013/06/19
Last modified on 2013/06/19

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Basic information
Public title Comparison between the clinical efficacy of linagliptin and sitagliptin
Acronym Comparison between the clinical efficacy of linagliptin and sitagliptin
Scientific Title Comparison between the clinical efficacy of linagliptin and sitagliptin
Scientific Title:Acronym Comparison between the clinical efficacy of linagliptin and sitagliptin
Region
Japan

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

Objectives
Narrative objectives1 To compare the clinical efficacy of linagliptin to sitagliptin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in HbA1c levels before and 24 weeks after drug administration and the influence of drug administration on renal function, liver function, and fat.
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 linagliptin
Interventions/Control_2 sitagliptin
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 Patients with Type 2 diabetes, in whom pharmacological treatment was recently initiated at our hospital
Key exclusion criteria 1. < 20 year-old or 80 year old =>
2. Cr>3.0mg/dl or eGFR<15ml/min
3. Pregnant or possibly pregnant women and women on lactation
4. allergy to DPP-4 inhibitors
5. poor control,HbA1c(NGSP) 8.5% =>
and patients who were thought as inadequate for this study by doctor in charge
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katoh Taiya
Organization Toyota Kosei Hospital
Division name Department of Endocrinology, Metabolism and Internal Medicine
Zip code
Address ibobara 500-1 jyousuichou Toyota,Aichi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Toyota Kosei Hospital
Division name Department of Endocrinology, Metabolism and Internal Medicine
Zip code
Address ibobara 500-1 jyousuichou Toyota,Aichi
TEL
Homepage URL
Email

Sponsor
Institute Toyota Kosei Hospital
Institute
Department

Funding Source
Organization none
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
2013 Year 06 Month 19 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
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 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 06 Month 19 Day
Last modified on
2013 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012872

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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