UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003072
Receipt No. R000003725
Scientific Title An open label multi facilities cooperation randomized control trial to verify renoprotective effects of improvement in postprandial hyperglycemia in diabetic nephropathy.
Date of disclosure of the study information 2010/04/01
Last modified on 2019/01/11

* 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 An open label multi facilities cooperation randomized control trial to verify renoprotective effects of improvement in postprandial hyperglycemia in diabetic nephropathy.
Acronym Clinical trial to verify relation between postprandial hyperglycemia ameliorating effect by mitiglinide and renoprotective effect
Mitiglinide can be expected to be more effective than glimepiride at reducing postprandial hyperglycemia and urinary albumin excretion.
Mitiglinide reduces urinary albumin excretion by ameliorating postprandial hyperglycemia in diabetic nephropathy.
Scientific Title An open label multi facilities cooperation randomized control trial to verify renoprotective effects of improvement in postprandial hyperglycemia in diabetic nephropathy.
Scientific Title:Acronym Clinical trial to verify relation between postprandial hyperglycemia ameliorating effect by mitiglinide and renoprotective effect
Mitiglinide can be expected to be more effective than glimepiride at reducing postprandial hyperglycemia and urinary albumin excretion.
Mitiglinide reduces urinary albumin excretion by ameliorating postprandial hyperglycemia in diabetic nephropathy.
Region
Japan

Condition
Condition Type 2 diabetic nephropathy patients.
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is examined that the improvement of postprandial hyperglycemia decreases urinary albumin excretion, and clarifies the mechanism.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Primary outcomes are the changes of postprandial plasma glucose levels, urinary albumin excretion and serum methylglyoxal levels, and urinary 8-OHdG, and MCP-1 excretions.
Key secondary outcomes Secondary outcomes are the changes in plasma glucose, insulin and free fatty acid levels according to meal load.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 This study is a prospective randomized control trial. The entry period of this study is two years. Subjects are type 2 diabetes with nephropathy. The Subjects are randomly assigned to two groups, mitiglinide administration group (30mg/day) and glimepride administration group.
Mitiglinide can be properly increased to 60mg/day when the anti-hyperglycemic effect is insufficient.
Interventions/Control_2 HbA1c, serum creatinine, postprandial plasma glucose levels, plasma methylglyoxal (MG) levels, serum lipids, free fatty acids (FFA), and urinary albumin excretion (ACR), and urinary excretions of monocyte chemoattractant protein (MCP)-1 and 8-hydroxydeoxyguanosine (8-OHdG) are determined before (baseline levels) and after the treatment for 6 months. We collect fasting and postprandial blood and urine.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria The subjects enrolled in the present study are type 2 diabetes with nephropathy, who visit our hospital and fulfilled the following criteria: 1) HbA1c of 6.0-10.0 %, 2) urinary albumin/creatinine ratio (ACR) higher than 30 mg/g Cre, 3) Blood pressure less than 160/100 mmHg.
Key exclusion criteria 1) Patient who has taken SU medicine within three months recent or been taking of SU medicine in present. 2) Patient for whom insulin treatment is necessary. 3) Patient who complicates severe and actively diabetic microangiopathy (retinopathy etc...). 4) Patient who complicates severe liver disease, kidney disease and heart disease. 5) Woman who has possibility of pregnancy or pregnancy and woman while suckling. 6) Patient who has already taken glinides. 7) It is a patient of the contraindication to administer the object medicine. 8) The doctor judged the patient's participation in the study to be improper.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sadayoshi Ito MD,PhD
Organization Tohoku University Graduate School of Medicine
Division name Division of Nephrology,Rndocrinology and Vascular Medicine Department of Internal Medicine
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7163
Email

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Ogawa MD,PhD
Organization Tohoku University Hospital
Division name Division of Nephrology, Endocrinology and Hypertension
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7166
Homepage URL
Email ogawa-s@hosp.tohoku.ac.jp

Sponsor
Institute Graduate School of Medicine, Tohoku Univwrsity
Institute
Department

Funding Source
Organization None
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 30

Other administrative information
Date of disclosure of the study information
2010 Year 04 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 Completed
Date of protocol fixation
2010 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
2015 Year 06 Month 01 Day
Date trial data considered complete
2015 Year 09 Month 01 Day
Date analysis concluded
2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 21 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003725

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.