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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026319
Receipt No. R000030224
Scientific Title The intervention trial of safety and efficacy of once-weekly Trelagliptin switched from daily DPP4 inhibitors for elderly patients with type 2 diabetes
Date of disclosure of the study information 2017/03/01
Last modified on 2017/02/27

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Basic information
Public title The intervention trial of safety and efficacy of once-weekly Trelagliptin switched from daily DPP4 inhibitors for elderly patients with type 2 diabetes
Acronym Safety and efficacy of Trelagliptin in elderly patients with type 2 diabetes
Scientific Title The intervention trial of safety and efficacy of once-weekly Trelagliptin switched from daily DPP4 inhibitors for elderly patients with type 2 diabetes
Scientific Title:Acronym Safety and efficacy of Trelagliptin in elderly patients with type 2 diabetes
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm safety snd efficacy of Trelagliptin in elderly patients with type 2 diabetes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Levels of glycohemoglobin at before and 12 weeks after switching
Key secondary outcomes Blood pressure, abdominal circumference, weight,frequency and severity of hypoglycemia, liver function, renal function

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Trelagliptin 100 mg will be administered once a week for 12 weeks.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes who are administered daily DPP4 inhibitors over 65 years of age
Key exclusion criteria Patients with renal dysfunction [creatinine clearance <50 ml/min or serum creatinine above 1.4 mg/dl(male), 1.2 mg/dl(female)]

Patients using insulin or GLP-1 receptor agonists
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Suzuki
Organization Kanagawa-ken Keiyu-kai Keiyu hospital
Division name Department of internal medicine
Zip code
Address 3-7-3, Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan. 220-8521(Zip code)
TEL 045-221-8181
Email t-suzuki@keiyu-hospital.com

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Suzuki
Organization Kanagawa-ken Keiyu-kai Keiyu hospital
Division name Department of internal medicine
Zip code
Address 3-7-3, Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan. 220-8521(Zip code)
TEL 045-221-8181
Homepage URL
Email t-suzuki@keiyu-hospital.com

Sponsor
Institute Kanagawa-ken Keiyu-kai Keiyu hospital
Institute
Department

Funding Source
Organization Kanagawa-ken Keiyu-kai Keiyu hospital
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
2017 Year 03 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 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
2017 Year 02 Month 27 Day
Last modified on
2017 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030224

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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