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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029739
Receipt No. R000033767
Scientific Title Impact of switching from once-weekly GLP1receptor agonist to once-weekly DPP4inhibitor(Omaligliptin)therapy on glycemic control parameters in type 2 diabetes patients undergoing hemodialysis.
Date of disclosure of the study information 2017/10/30
Last modified on 2017/10/27

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Basic information
Public title Impact of switching from once-weekly GLP1receptor agonist to once-weekly DPP4inhibitor(Omaligliptin)therapy on glycemic control parameters in type 2 diabetes patients undergoing hemodialysis.
Acronym DO study
Scientific Title Impact of switching from once-weekly GLP1receptor agonist to once-weekly DPP4inhibitor(Omaligliptin)therapy on glycemic control parameters in type 2 diabetes patients undergoing hemodialysis.
Scientific Title:Acronym DO study
Region
Japan

Condition
Condition Type 2 daiabetes
Chronic renal failure
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 There is few reports that estimate impact of switching from once-weekly GLP1 receptor agonist to once-weekly DPP4 inhibitor(Omaligliptin) therapy on glycemic control parameters in type 2 diabetes patients undergoing hemodialysis.We estimate blood glucose level by continuous glucose monitoring(CGM).

Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glucose estimated by CGM
Key secondary outcomes GA,height,weight,BP,HR,WBC,RBC,Hb,Ht,PLT,TG,HDL-CHO,LDL-CHO,AST,ALT,gamma-GTP,BUN,UA,CRN,Na,K,Cl

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 Dulaglutide(0.75mg)/week for 3 weeks more then switch to Omarigliptin for 4 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Under 10.0% HbA1c for last 3 months or more
2.Agreement for the use of data
3.Under hemodialysis for 6 mouths or more
Key exclusion criteria 1.Using other GLP1 analog formulation
2.Using other DPP4 inhibitor
3.Hypersensitivity for Dulaglutide and Omarigliptin
4.Severe ketosis,Diabetic coma and pre-coma,type 1 diabetes
5.Severe infection,pre and post operation ,severe trauma,such state with necessity of blood suger management by Insulin treatment
6.Pregnant woman,woman suspected of being pregnant,woman in breast-feeding
7.Patiants recognized to be inappropriate for study by medical basis of doctor
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasurou Kumeda
Organization Minamiosaka hospital
Division name Department of internal medicine
Zip code
Address 1-18-18 Higashikagaya Suminoe-ku Osaka city Osaka Japan
TEL 06-6685-0221
Email snorikoho2@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Sakuma
Organization Minamiosaka hospital
Division name Department of internal medicine
Zip code
Address 1-18-18 Higashikagaya Suminoe-ku Osaka city Osaka Japan
TEL 06-6685-0221
Homepage URL
Email snorikoho2@gmail.com

Sponsor
Institute Minamiosaka hospital
Institute
Department

Funding Source
Organization Self funding
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 10 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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 30 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 10 Month 27 Day
Last modified on
2017 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033767

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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