UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000725 |
|---|---|
| Receipt number | R000000869 |
| Scientific Title | Glycemic control and Oxidative stress with Glimepiride or Nateglinide alone in type 2 OHA naive diabetic patients. |
| Date of disclosure of the study information | 2007/05/30 |
| Last modified on | 2012/07/03 19:53:11 |
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Basic information
Public title
Glycemic control and Oxidative stress with Glimepiride or Nateglinide alone in type 2 OHA naive diabetic patients.
Acronym
Glycemic control and Oxidative stress with Glimepiride or Nateglinide alone in type 2 OHA naive Diabetic patients.
Scientific Title
Glycemic control and Oxidative stress with Glimepiride or Nateglinide alone in type 2 OHA naive diabetic patients.
Scientific Title:Acronym
Glycemic control and Oxidative stress with Glimepiride or Nateglinide alone in type 2 OHA naive Diabetic patients.
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of glimepiride and nateglinide on glycaemic control and oxidative stress parameters such as 8-OhdG, in OHA naive patients insufficiently controlled by diet and exercise alone or a-GI monotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of HbA1c
Key secondary outcomes
1)FPG, Fasting IRI, Achievement ratio of HbA1c below 6.5%.
2)TC,TG,HDL-C,LDL-C,BW,BMI,HOMA-IR
3)Urinal 8-OHdG, hs-CRP, Adiponectin,
High Molecular Weight Adiponectin, High Sensitive TNF-a, TGF-b
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Glimepiride group: Starting dose will be 0.5mg/day or 1mg/day at before breakfast or after breakfast depending on the conditions of patients. Maximum dosage is 6mg/day, and treatment period is for 6 month
Treatment period is for 6 month.
Interventions/Control_2
Nateglinide group: Starting dose should be determined depending on the conditions of patients. Timing of dosing should be before each (maximum 360mg/day).
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
OHA naive type 2 diabetic patients with HbA1c 6.5%<=HbA1c<8.0, controlled by Diet and Exercise alone or a-GI mono therapy for more than 3 months.
Key exclusion criteria
Exclusion Criteria:
1) Patients except type 2 diabetic patients.
2) Patients taking Probucol, vitamin E and/or vitamin C.
3) Alcoholic,or heavy drinker.
4) Patients operated malignant and gastro extraction.
5) Patients with serious complications of DM.
Nephropathy:*. Retinopathy:**
6) Drug anaphylaxis patient.
7) Pregnant or patients who plan to carry, or currently breast-feeding woman.
8) Patients who were judged inappropriate to participate in this study by the doctor of study director or cooperative
*Proteinuria >= 1g/day
** Stage of preproliferative and proliferative retinopaty by Davis classification
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Odawara |
Organization
Tokyo Medical University
Division name
The 3rd Department of Internal Medicine
Zip code
Address
160-0023 6-7-1, Shinjuku-ku, Nishi-shinjuku, Tokyo
TEL
03-3342-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Miwa |
Organization
Tokyo Medical University
Division name
The 3rd Department of Internal Medicine
Zip code
Address
160-0023 6-7-1, Shinjuku ku, Nishi shinjuku, Tokyo
TEL
03-3342-6111
Homepage URL
Sponsor or person
Institute
Tokyo Medical University
The 3rd Department of Internal Medicine
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
Ryokuseikai Hospital
Akishima Hospital
Ryokuhuso Hospital
Niiza Shiki Chuo general Hospital
Nishi Tokyo Chuo general Hospital
Toda Chuo general Hospital
Ebara Hospital
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2006 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 05 | Month | 27 | Day |
Last modified on
| 2012 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000869
