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

Kissei

Status and phase: Completed; Phase 3

Conditions: Diabetes

Treatments: Drug: Mitiglinide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00461617

KAD1301

Details and patient eligibility

About

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

Enrollment: 291 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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291 participants in 1 patient group

2

Active Comparator group

Description:

Nateglinide 120 mg TID

Treatment:

Drug: Mitiglinide