Double-Blind Comparison Between Mitiglinide and Nateglinide in Type 2 Diabetic Patients

Sponsor

Kissei Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00461617

Collaborator

(none)

291

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: Mitiglinide	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

291 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Multicentre, Double-Dummy, Randomized, Double-Blind Comparison Between Mitiglinide and Nateglinide in the Patients With Type 2 Diabetes

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 Nateglinide 120 mg TID	Drug: Mitiglinide 10mg tablet, 10mg TID Other Names: Glufast

Arm

Intervention/Treatment

Active Comparator: 2

Nateglinide 120 mg TID

Drug: Mitiglinide

10mg tablet, 10mg TID

Other Names:

Glufast

Outcome Measures

Primary Outcome Measures

Hemoglobin A1C (HbA1C) [-2, 0, 4, 8, 10, 12, 16, 20 week]

Secondary Outcome Measures

Fasting plasma glucose level (FPG) [0, 4, 8, 12, 16, 20 week]
Two-hour postprandial glucose level (PPG2) [0, 12, 20 week]
One-hour postprandial glucose level (PPG1) [0, 12, 20 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 diabetes patients with inadequate control of blood glucose with diet and/or exercise therapy

Exclusion Criteria:

Type 1 diabetes patients
Patients who require treatment with insulin
Patients with severe diabetic complications (neuropathy, retinopathy or nephropathy)
Patients with severe ketosis, diabetic coma or precoma
Patients complicated with severe hepatic diseases
Patients complicated with severe renal diseases
Patients complicated with severe hypertension
Patients complicated with severe cardiac disease
Pregnant women or women possible to be pregnant, nursing women, or women who want to become pregnant during the study period