Combination of Glinides With Premixed Insulin

Phase 4

Completed

• Conditions: Type 2 Diabets Mellitus

• Registration Number: NCT00369148
• Lead Sponsor: Keio University

Brief Summary

Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.

Detailed Description

Type 2 diabetic patients undergoing twice daily injections of premixed insulin are administered glinides (10mg of mitiglinide or 90 mg of nateglinide) at lunchtime without changing their insulin regimen. Twelve weeks after administration of the glinides, they are discontinued. HbA1c levels at the start of glinide administration, 12 weeks after administration, and 12 weeks after discontinuation are measured.

Study Timeline

• Study Start: 2004-07
• Study Completion: 2006-03
• Study First Submitted: 2006-08-28
• Study First Submitted QC: 2006-08-28
• Study First Posted: 2006-08-29
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-25
• Last Update Posted: 2009-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinical diagnosis of type 2 diabetes
• Who undergoes twice daily injection of premixed insulin
• Whose HbA1c is more than 6.5% and less than 8.0%

Exclusion Criteria

• Whose change of HbA1c is more than 1.0% during 12 weeks observational period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
glycohemoglobin

Secondary Outcome Measures

Name	Time	Method
anhydroglucitol
lipid profile
body weight
blood pressure

Trial Locations

Locations (6)

Hamamatsu Red Cross Hospital; 🇯🇵 Hamamatsu, Shizuoka, Japan

Kitasato Institute Hospital; 🇯🇵 Minato-ku, Tokyo, Japan

Saiseikai Central Hospital; 🇯🇵 Minato-ku, Tokyo, Japan

Keio University Hospital; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Tokyo Metropolitan Ohtsuka Hospital; 🇯🇵 Toshima-ku, Tokyo, Japan

Nippon Kokan Hospital; 🇯🇵 Kawasaki, Kanagawa, Japan