Combination of Glinides With Premixed Insulin

Type 2 Diabets Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369148
• Other study ID #: CS-NHK2
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2006
• Last updated: August 25, 2009
• Start date: July 2004
• Est. completion date: March 2006

Study information

• Verified date: August 2009
• Source: Keio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabets Mellitus

Intervention

Drug:
• nateglinide(drug) mitiglinide(drug)

Locations

Country	Name	City	State
Japan	Hamamatsu Red Cross Hospital	Hamamatsu	Shizuoka
Japan	Nippon Kokan Hospital	Kawasaki	Kanagawa
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

Sponsors (1)

Lead Sponsor	Collaborator
Keio University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycohemoglobin
Secondary	anhydroglucitol
Secondary	lipid profile
Secondary	body weight
Secondary	blood pressure