We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combination of Glinides With Premixed Insulin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00369148
First Posted: August 29, 2006
Last Update Posted: August 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Keio University
  Purpose
Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.

Condition Intervention Phase
Type 2 Diabets Mellitus Drug: nateglinide(drug) mitiglinide(drug) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Usefulness of Combination Therapy of Rapid Acting Insulin Secretagogue (Glinide) With Premixed Insulin in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Keio University:

Primary Outcome Measures:
  • glycohemoglobin

Secondary Outcome Measures:
  • anhydroglucitol
  • lipid profile
  • body weight
  • blood pressure

Estimated Enrollment: 60
Study Start Date: July 2004
Estimated Study Completion Date: March 2006
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369148


Locations
Japan
Nippon Kokan Hospital
Kawasaki, Kanagawa, Japan, 210-0852
Hamamatsu Red Cross Hospital
Hamamatsu, Shizuoka, Japan, 430-0907
Saiseikai Central Hospital
Minato-ku, Tokyo, Japan, 108-0073
Kitasato Institute Hospital
Minato-ku, Tokyo, Japan, 108-8642
Keio University Hospital
Shinjuku-ku, Tokyo, Japan, 160-8582
Tokyo Metropolitan Ohtsuka Hospital
Toshima-ku, Tokyo, Japan, 170-8476
Sponsors and Collaborators
Keio University
Investigators
Study Chair: Akira Shimada, MD, PhD Keio University School of Medicine
Study Director: Yoshihito Atsumi, MD Saiseikai Central Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00369148     History of Changes
Other Study ID Numbers: CS-NHK2
First Submitted: August 28, 2006
First Posted: August 29, 2006
Last Update Posted: August 26, 2009
Last Verified: August 2009

Keywords provided by Keio University:
glinides
premixed insulin
combination therapy
glycemic control

Additional relevant MeSH terms:
Insulin, Globin Zinc
Nateglinide
Mitiglinide
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs