Combination of Glinides With Premixed Insulin

August 25, 2009 updated by: Keio University

Evaluation of Usefulness of Combination Therapy of Rapid Acting Insulin Secretagogue (Glinide) With Premixed Insulin in Type 2 Diabetes

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 210-0852
        • Nippon Kokan Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 430-0907
        • Hamamatsu Red Cross Hospital
    • Tokyo
      • Minato-ku, Tokyo, Japan, 108-0073
        • Saiseikai Central Hospital
      • Minato-ku, Tokyo, Japan, 108-8642
        • Kitasato Institute Hospital
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Toshima-ku, Tokyo, Japan, 170-8476
        • Tokyo Metropolitan Ohtsuka Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
glycohemoglobin

Secondary Outcome Measures

Outcome Measure
blood pressure
body weight
anhydroglucitol
lipid profile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keio University

Investigators

  • Study Chair: Akira Shimada, MD, PhD, Keio University
  • Study Director: Yoshihito Atsumi, MD, Saiseikai Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

August 28, 2006

First Submitted That Met QC Criteria

August 28, 2006

First Posted (Estimate)

August 29, 2006

Study Record Updates

Last Update Posted (Estimate)

August 26, 2009

Last Update Submitted That Met QC Criteria

August 25, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-NHK2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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