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Combination of Glinides With Premixed Insulin

This study has been completed.
Sponsor:
Information provided by:
Keio University
ClinicalTrials.gov Identifier:
NCT00369148
First received: August 28, 2006
Last updated: August 25, 2009
Last verified: August 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369148

Locations
Japan
Nippon Kokan Hospital
Kawasaki, Kanagawa, Japan, 210-0852
Hamamatsu Red Cross Hospital
Hamamatsu, Shizuoka, Japan, 430-0907
Kitasato Institute Hospital
Minato-ku, Tokyo, Japan, 108-8642
Saiseikai Central Hospital
Minato-ku, Tokyo, Japan, 108-0073
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

No publications provided

ClinicalTrials.gov Identifier: NCT00369148     History of Changes
Other Study ID Numbers: CS-NHK2
Study First Received: August 28, 2006
Last Updated: August 25, 2009
Health Authority: Japan: Institutional Review Board

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

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014