UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037106
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email labmed@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041679

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.