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 |
Comparative study of glimepiride and nateglinide on glycemic control in patients with type 2 diabetes mellitus treated with voglibose
Comparative study of glimepiride and nateglinide in type 2 diabetes mellitus
Comparative study of glimepiride and nateglinide on glycemic control in patients with type 2 diabetes mellitus treated with voglibose
Comparative study of glimepiride and nateglinide in type 2 diabetes mellitus
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
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.
Safety,Efficacy
Changes in HbA1c levels
Changes in postprandial plasma glucose concentrations
Changes in 1,5-AG levels
Changes in glycoalbumin levels
Changes in insulin concentrations
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
NO
Numbered container method
2
Treatment
Medicine |
Administration of glimepiride for 16 wks
Administration of nateglinide for 16 wks
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
60
1st name | |
Middle name | |
Last name | Jiro Nakamura |
Nagoya University Graduate School of Medicine
Department of Endocrinology and Diabetes
65 Tsuruma-cho, Showa-ku, Nagoya
052-744-2187
1st name | |
Middle name | |
Last name |
Nagoya University Graduate School of Medicine
Department of Endocrinology and Diabetes
052-744-2187
Nagoya University Graduate School of Medicine
Nagoya University Graduate School of Medicine
JAPAN
NO
2009 | Year | 01 | Month | 01 | Day |
Unpublished
Preinitiation
2006 | Year | 09 | Month | 30 | Day |
2007 | Year | 05 | Month | 01 | Day |
2008 | Year | 05 | Month | 01 | Day |
2008 | Year | 08 | Month | 01 | Day |
2008 | Year | 10 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2007 | Year | 04 | Month | 11 | Day |
2007 | Year | 04 | Month | 11 | Day |
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 |