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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000000676
Receipt No. R000000813
Scientific Title Comparative study of glimepiride and nateglinide on glycemic control in patients with type 2 diabetes mellitus treated with voglibose
Date of disclosure of the study information 2009/01/01
Last modified on 2007/04/11

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Basic information
Public title Comparative study of glimepiride and nateglinide on glycemic control in patients with type 2 diabetes mellitus treated with voglibose
Acronym Comparative study of glimepiride and nateglinide in type 2 diabetes mellitus
Scientific Title Comparative study of glimepiride and nateglinide on glycemic control in patients with type 2 diabetes mellitus treated with voglibose
Scientific Title:Acronym Comparative study of glimepiride and nateglinide in type 2 diabetes mellitus
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the efficacy on glycemic control and safety of glimepiride or nateglinide in patients with type 2 diabetes mellitus inadequately treated with voglibose for 12 wks or more.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in HbA1c levels
Changes in postprandial plasma glucose concentrations
Key secondary outcomes Changes in 1,5-AG levels
Changes in glycoalbumin levels
Changes in insulin concentrations

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of glimepiride for 16 wks
Interventions/Control_2 Administration of nateglinide for 16 wks
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 1) Type 2 diabetic patients treated with voglibose for 12 wks or more
2) HbA1c level: 6.5%<=HbA1c<8.0%
3) Patients with HbA1c fluctuation of 0.5% or less during the 3 months prior to the beginning of the study
4) Patients without severe heart, liver or kidney diseases
5) Age: 20 to 79 years old
6) Outpatients
Key exclusion criteria 1) Patients without type 2 diabetes
2) Patients with alcohol abuse or excessive intake of alcoholic beverages
3) Patients with severe diabetic complications*
*nephropathy>=stage 3A
*retinopathy>=preproliferative stage in Davis classifications
4) Patients with liver dysfunction (AST and ALT>=80 IU/L) or renal dysfunction (serum creatinie>=1.5mg/dl)
5) Patients with an allergy to any drug
6) Pregnant women and women at child bearing age and not taking adequate contraceptions
7) Patients decided to be irrelevant by the investigators
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jiro Nakamura
Organization Nagoya University Graduate School of Medicine
Division name Department of Endocrinology and Diabetes
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya
TEL 052-744-2187
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagoya University Graduate School of Medicine
Division name Department of Endocrinology and Diabetes
Zip code
Address
TEL 052-744-2187
Homepage URL
Email

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

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

Other administrative information
Date of disclosure of the study information
2009 Year 01 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 Preinitiation
Date of protocol fixation
2006 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2008 Year 05 Month 01 Day
Date of closure to data entry
2008 Year 08 Month 01 Day
Date trial data considered complete
2008 Year 10 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 04 Month 11 Day
Last modified on
2007 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000813

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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