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

Phase 3

Completed

• Conditions: Diabetes
• Interventions: Drug: Mitiglinide

• Registration Number: NCT00461617
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Status Verified: 2007-04
• Study First Submitted: 2007-04-17
• Study First Submitted QC: 2007-04-17
• Study First Posted: 2007-04-18
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Last Update Submitted: 2008-10-20
• Last Update Posted: 2008-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Mitiglinide	Nateglinide 120 mg TID

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C (HbA1C)	-2, 0, 4, 8, 10, 12, 16, 20 week

Secondary Outcome Measures

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