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

This study has been completed.
Sponsor:
Information provided by:
Sanwa Kagaku Kenkyusho Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00334503
First received: June 5, 2006
Last updated: October 8, 2008
Last verified: October 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Miglitol
U.S. FDA Resources

Further study details as provided by Sanwa Kagaku Kenkyusho Co., Ltd.:

  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
Aichi, Japan
Chiba, Japan
Fukuoka, Japan
Gunma, Japan
Hokkaido, Japan
Ibaragi, Japan
Kagoshima, Japan
Kanagawa, Japan
Kumamoto, Japan
Miyazaki, Japan
Oita, Japan
Osaka, Japan
Saitama, 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

No publications provided

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

Keywords provided by Sanwa Kagaku Kenkyusho Co., Ltd.:
alpa-glucosidase inhibitor,Biguanide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Miglitol
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2012