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Double-Blind Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Miglitol
Sponsored by
Sanwa Kagaku Kenkyusho Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring alpa-glucosidase inhibitor,Biguanide

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 2 diabetic patients treated with Biguanide Criteria for postprandial plasma glucose and HbA1c are met Exclusion Criteria: Type 1 diabetes Patients treated with other antidiabetic drugs or Insulin

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 26, 2006
Last Updated
October 8, 2008
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00334399
Brief Title
Double-Blind Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
alpa-glucosidase inhibitor,Biguanide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Miglitol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetic patients treated with Biguanide Criteria for postprandial plasma glucose and HbA1c are met Exclusion Criteria: Type 1 diabetes Patients treated with other antidiabetic drugs or Insulin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Group, Clinical Development Dept.
Organizational Affiliation
Sanwa Kagaku Kenkyusho Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Aichi
Country
Japan
City
Chiba
Country
Japan
City
Fukuoka
Country
Japan
City
Gifu
Country
Japan
City
Gunma
Country
Japan
City
Hokkaido
Country
Japan
City
Ibaragi
Country
Japan
City
Kanagawa
Country
Japan
City
Kumamoto
Country
Japan
City
Miyazaki
Country
Japan
City
Osaka
Country
Japan
City
Saitama
Country
Japan
City
Tochigi
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Double-Blind Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide

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