UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003072 |
|---|---|
| Receipt number | 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 | 2022/04/06 10:15:18 |
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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 | Sadayoshi |
| Middle name | |
| Last name | Ito |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Nephrology,Rndocrinology and Vascular Medicine Department of Internal Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7163
ogawa-s@hosp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University Hospital
Division name
Division of Nephrology, Endocrinology and Hypertension
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7166
Homepage URL
ogawa-s@hosp.tohoku.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Tohoku Univwrsity
Institute
Department
Personal name
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
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
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003725
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