UMIN-CTR Clinical Trial

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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