Combination of Glinides With Premixed Insulin

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00369148

Enrollment

Registered

2006-08-29

Start date

2004-07-31

Completion date

2006-03-31

Last updated

2009-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabets Mellitus

Keywords

glinides, premixed insulin, combination therapy, glycemic control

Brief summary

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

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.

Interventions

DRUGnateglinide(drug) mitiglinide(drug)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
glycohemoglobin	—

Secondary

Measure	Time frame
anhydroglucitol	—
lipid profile	—
body weight	—
blood pressure	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026