Combination of Glinides With Premixed Insulin

Keio University

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabets Mellitus

Treatments: Drug: nateglinide(drug) mitiglinide(drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT00369148

CS-NHK2

Details and patient eligibility

About

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

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)