Open Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide

This study has been completed.

Sponsored by:	Sanwa Kagaku Kenkyusho Co., Ltd.
Information provided by:	Sanwa Kagaku Kenkyusho Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00334503

Purpose

The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in patients with Type2 Diabetes Mellitus treated with Biguanide.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Miglitol	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Miglitol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:	20 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetic patients with Biguanide treatment
Criteria for postprandial plasma glucose and HbA1c are met

Exclusion Criteria:

Type 1 diabetes
Patients treated with other antidiabetic drugs or Insulin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334503

Locations

Japan

Hokkaido, Japan

Ibaragi, Japan

Gunma, Japan

Saitama, Japan

Chiba, Japan

Kanagawa, Japan

Kagoshima, Japan

Osaka, Japan

Fukuoka, Japan

Kumamoto, Japan

Oita, Japan

Miyazaki, Japan

Aichi, Japan

Sponsors and Collaborators

Sanwa Kagaku Kenkyusho Co., Ltd.

Investigators

Study Director:

Clinical Study Group, Clinical Development Dept.

Sanwa Kagaku Kenkyusho Co., Ltd.

More Information

Study ID Numbers:	MG1009
Study First Received:	June 5, 2006
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00334503
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanwa Kagaku Kenkyusho Co., Ltd.:

alpa-glucosidase inhibitor,Biguanide

Study placed in the following topic categories:

Miglitol
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009