UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000676
Receipt number 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 16:14:01

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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 or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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