Combination of Glinides With Premixed Insulin

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. Identifier: NCT00369148
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : August 26, 2009
Information provided by:
Keio University

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

Condition or disease Intervention/treatment Phase
Type 2 Diabets Mellitus Drug: nateglinide(drug) mitiglinide(drug) Phase 4

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  (Clinical Trial)
Enrollment : 60 participants
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
Study Start Date : July 2004
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. glycohemoglobin

Secondary Outcome Measures :
  1. anhydroglucitol
  2. lipid profile
  3. body weight
  4. blood pressure

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00369148

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
Study Chair: Akira Shimada, MD, PhD Keio University
Study Director: Yoshihito Atsumi, MD Saiseikai Central Hospital Identifier: NCT00369148     History of Changes
Other Study ID Numbers: CS-NHK2
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: August 26, 2009
Last Verified: August 2009

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

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