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

NCT ID: NCT00461617

Last Updated: 2008-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Diabetes

Keywords

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diabetes rapid and short acting insulin secretagogue α-glucosidase inhibitor HbA1C insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Nateglinide 120 mg TID

Group Type ACTIVE_COMPARATOR

Mitiglinide

Intervention Type DRUG

10mg tablet, 10mg TID

Interventions

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Mitiglinide

10mg tablet, 10mg TID

Intervention Type DRUG

Other Intervention Names

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Glufast

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Zhongshan Hospital, Fudan University

Principal Investigators

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Xin Gao, Professor

Role: PRINCIPAL_INVESTIGATOR

Endocrinology Dept. of Fudan University Zhongshan Hospital

Other Identifiers

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KAD1301

Identifier Type: -

Identifier Source: org_study_id