Status:

COMPLETED

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

Lead Sponsor:

Kissei Pharmaceutical Co., Ltd.

Conditions:

Diabetes

Eligibility:

All Genders

25-70 years

Phase:

PHASE3

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.

Eligibility Criteria

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

Key Trial Info

Start Date :

August 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2007

Estimated Enrollment :

291 Patients enrolled

Trial Details

Trial ID

NCT00461617

Start Date

August 1 2006

End Date

July 1 2007

Last Update

October 21 2008

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