Back to resultsOpen Trial of Miglitol in Type 1 Diabetic Patients With Insulin Treatment
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Miglitol
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring alpha-glucosidase inhibitor,Insulin
Eligibility Criteria
Inclusion Criteria: Type1 Diabetes Criteria of postprandial glucose and HbA1c are met Exclusion Criteria: Type2 Diabetes Patients with antidiabetic drugs The other exclusion criteria are met
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00213109
First Posted
September 13, 2005
Last Updated
September 20, 2006
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00213109
Brief Title
Open Trial of Miglitol in Type 1 Diabetic Patients With Insulin Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
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 evaluate the clinical efficacy and safety of Miglitol in patients with Type1 Diabetes Mellitus treated with insulin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
alpha-glucosidase inhibitor,Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Miglitol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type1 Diabetes
Criteria of postprandial glucose and HbA1c are met
Exclusion Criteria:
Type2 Diabetes
Patients with antidiabetic drugs
The other exclusion criteria are met
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Promotion Group
Organizational Affiliation
Sanwa Kagaku Kenkyusho Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Chiba
Country
Japan
City
Fukuoka
Country
Japan
City
Gifu
Country
Japan
City
Ibaraki
Country
Japan
City
Kanagawa
Country
Japan
City
Kumamoto
Country
Japan
City
Oita
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Open Trial of Miglitol in Type 1 Diabetic Patients With Insulin Treatment
We'll reach out to this number within 24 hrs