UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010159 |
|---|---|
| Receipt number | R000011782 |
| Scientific Title | Effect of Haemodialysis on the Plasma glucose profile and Plasma level of Liraglutide in People with Type 2 Diabetes Mellitus and End Stage Renal Disease |
| Date of disclosure of the study information | 2013/03/08 |
| Last modified on | 2013/09/25 14:50:09 |
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Basic information
Public title
Effect of Haemodialysis on the Plasma glucose profile and Plasma level of Liraglutide in People with Type 2 Diabetes Mellitus and End Stage Renal Disease
Acronym
Effect of Haemodialysis on the Plasma glucose profile and Plasma level of Liraglutide in People with Type 2 Diabetes Mellitus and End Stage Renal Disease
Scientific Title
Effect of Haemodialysis on the Plasma glucose profile and Plasma level of Liraglutide in People with Type 2 Diabetes Mellitus and End Stage Renal Disease
Scientific Title:Acronym
Effect of Haemodialysis on the Plasma glucose profile and Plasma level of Liraglutide in People with Type 2 Diabetes Mellitus and End Stage Renal Disease
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our primary objective will be to assess the efficacy of liraglutide in controlling blood glucose levels and evaluate its effect on hypoglycemia in type 2 diabetes patients with ESRD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma glucose profile (CGM) on-haemodialysis and off-haemodialysis
Key secondary outcomes
Plasma liragutide levels while on-haemodialysis and off-haemodialysis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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.Male and female subjects with type 2 Diabetes Mellitus
2.Age ≥20 years
3.Treated with stable dose of liraglutide of 0.6mg or 0.9mg for at least 2 weeks.
4.GA 30% or less
5.Able to provide informed consent before any trial-related activities.
Key exclusion criteria
1-Type 1 Diabetes Mellitus
2-Previous treatment with other incretin mimetics within the previous three months before screening.
3-Insulin-requiring type 2 Diabetes Mellitus
4-Impaired hepatic function, measured as serum glutamic oxaloacetic transaminase [sGOT ( Aspartate Aminotransferase , ASAT)] or serum glutamic pyruvic transaminase (sGPT) ≥ 100 IU/L
5-Unstable cardiovascular or cerebrovascular disease.
6-Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
7-Female of childbearing potential who are not using adequate contraceptive menthods
8-Known or suspected allergy to trial medication(s), excipients, or related products.
9-Any contraindications to liraglutide.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Osonoi |
Organization
Nakakinen Clinic
Division name
Director
Zip code
Address
745-5,Nakadai,Naka-city,Ibaraki-ken,311-0113,Japan
TEL
029-353-2800
t-osonoi@kensei-kai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Ofuchi |
Organization
Nakakinen Clinic
Division name
Director
Zip code
Address
745-5,Nakadai,Naka-city,Ibaraki-ken,311-0113,Japan
TEL
029-353-2800
Homepage URL
k-ofuchi@kensei-kai.com
Sponsor or person
Institute
Nakakinen Clinic
Institute
Department
Personal name
Funding Source
Organization
Novo Nordisk Pharma Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
那珂記念クリニック
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 08 | 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 | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 30 | Day |
Other
Other related information
prospective
Management information
Registered date
| 2013 | Year | 03 | Month | 04 | Day |
Last modified on
| 2013 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011782
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
