Three-Arm Comparative Study of Miglitol and Mitiglinide Alone and in Combination -Efficacy and Safety Studies

Not Applicable

• Conditions: type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000010282
• Lead Sponsor: Kawasaki Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-07-26
• Study Start: 2013-03-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Patients who have undergone dietary/exercise therapy of less than 8 weeks since diabetes diagnosis (2)Patients who have undergone biguanide therapy of less than 8 weeks (3)Patients who are undergoing treatment with a sulfonylurea agent (4)Patients who are undergoing treatment with a thiazolidine agent (5)Patients who are undergoing treatment with an arufa-glucosidase inhibitor (Patients who had prior treatment with voglibose or acarbose were allowed to participate in this study, provided that 8 weeks or longer have passed since the termination of the oral treatment.) (6)Patients who are undergoing treatment with a rapid-acting insulin secretagogue (Patients who had prior treatment with nateglinide were allowed to participate in this study, provided that 8 weeks or longer have passed since the termination of the oral treatment.) (7)Patients who are undergoing concomitant treatment with an arufa-glucosidase inhibitor and a rapid-acting insulin secretagogue (8)Patients who are undergoing or who require insulin treatment (9)Patients with severe ketosis or in a diabetic coma or pre-coma (10)Patients with severe infection, perioperative, severe injury (11)Patients with history of hypersensitivity to any ingredient in the study drug (12)Women who are pregnant or who may be pregnant (13)Other patients whom their physicians in charge considered unsuitable for inclusion in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic control meal-loading tests:plasma glucose, serum insulin, total GLP-1, total GIP HbA1c, 1,5-AG

Secondary Outcome Measures

Name	Time	Method
high-molecular weight adiponectin, high sensitivity C reactive protein (hs-CRP), 8-Hydroxydeoxyguanosine(8-OhdG),