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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000725
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokyo Medical University
The 3rd Department of Internal Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000869

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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