UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037106 |
|---|---|
| Receipt number | R000041679 |
| Scientific Title | Clinical study of GLP-1 receptor agonist (Exenatide) for type 2 diabetes patients with diabetic nephropathy |
| Date of disclosure of the study information | 2019/06/19 |
| Last modified on | 2019/06/19 10:13:41 |
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Basic information
Public title
Clinical study of GLP-1 receptor agonist (Exenatide) for type 2 diabetes patients with diabetic nephropathy
Acronym
Clinical study of exenatide for type 2 diabetes patients with diabetic nephropathy
Scientific Title
Clinical study of GLP-1 receptor agonist (Exenatide) for type 2 diabetes patients with diabetic nephropathy
Scientific Title:Acronym
Clinical study of exenatide for type 2 diabetes patients with diabetic nephropathy
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Accumulated cases where single administration of a GLP-1 agonist was administered to type 2 diabetes patients with inadequate glycemic control with diabetic nephropathy, or accumulated cases where the sulfonylurea drug ,thiazolidine drug, biguanide drug, a-glucosidase inhibitor, glinide drug were coadministered, GLP-1 action to investigate the efficacy and safety of the drug's hypoglycemic action and its effect on renal function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change of delta eGFR at 12 weeks before and after administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer GLP-1 receptor agonist (Exenatide)
1. In principle, this drug is administered within 60 minutes before morning supper and not after meals.
2. The administration of this drug starts with 5 ug once a day, twice a day. After increasing the dose from 5 ug to 10 ug, hypoglycemia and gastrointestinal disorders tend to increase. Therefore, at least one month after the start of administration, follow-up, and in consideration of efficacy and safety, Carefully judge whether to increase the amount to 10 ug at once or twice a day.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who meet the criteria below
1) HbA1c (NGSP): 7.0% or more and less than 10%
2) Patients aged 20 years or older and less than 80 years regardless of gender
3) Diabetic nephropathy stage 2-3 (diagnostic criteria attached)
4) Patients who can obtain written consent to participate in this clinical research
Key exclusion criteria
Patients who fall under any of the following are excluded from this clinical study.
1) Patients who fall under the contraindication for GLP-1 receptor agonist
2) Patients participating in other clinical research
3) Pregnant women, pregnant women, lactating women or women who may have pregnancy
4) Patients with other serious complications
5) Patients judged to be unsuitable as a target by the judgment of other doctors
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Murao |
Organization
Kagawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
Ikenobe 1750-1, Miki-cho, Kita-gun, Kagawa
TEL
0878985111
labmed@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensaku |
| Middle name | |
| Last name | Fukunaga |
Organization
Kagawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
Ikenobe 1750-1, Miki-cho, Kita-gun, Kagawa
TEL
0878985111
Homepage URL
labmed@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa University of Medicine Ethics Committee
Address
Ikenobe 1750-1, Miki-cho, Kita-gun, Kagawa
Tel
0878985111
chiken@med.kagawa-u.ac.jp
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
| 2019 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 19 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041679
| Research Plan | |
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| 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 |
