Double-Blind Comparison Between Mitiglinide and Nateglini... | NCT00461617

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

NCT00461617

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Oct 21, 2008Estimated

Enrollment

291Actual

Phase

Phase 3

Conditions

Diabetes

Interventions

Mitiglinide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Apr 17, 2007

First Submission Date that Met QC Criteria

Apr 17, 2007

First Posted Date

Apr 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2008

Last Update Posted Date

Oct 21, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

291Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Active Comparator	Nateglinide 120 mg TID	Drug: Mitiglinide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mitiglinide	Drug	10mg tablet, 10mg TID	2	Glufast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin A1C (HbA1C)		-2, 0, 4, 8, 10, 12, 16, 20 week

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xin Gao, Professor	Endocrinology Dept. of Fudan University Zhongshan Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D005215	Fasting
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C087255	mitiglinide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided