Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors

NCT ID: NCT00928889

Last Updated: 2012-05-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-06-30

Brief Summary

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This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nateglinide 120 mg

Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.

Group Type EXPERIMENTAL

Nateglinide 120 mg

Intervention Type DRUG

Nateglinide 120 mg was supplied as tablets.

Acarbose 50 mg

Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.

Group Type ACTIVE_COMPARATOR

Acarbose 50 mg

Intervention Type DRUG

Acarbose 50 mg was supplied as tablets.

Interventions

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Nateglinide 120 mg

Nateglinide 120 mg was supplied as tablets.

Intervention Type DRUG

Acarbose 50 mg

Acarbose 50 mg was supplied as tablets.

Intervention Type DRUG

Other Intervention Names

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Starlix Glucobay

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed type 2 diabetes mellitus patients
* HbA1c \> 6.5 and \< 9.0%
* Fasting fingertip capillary blood glucose (FCBG) \< 9 mmol/L after 2 weeks diet control

Exclusion Criteria

* History of acute metabolic complications in the past 3 months or of severe diabetic complications or severe infections or active substance abuse
* Liver disease
* Patients under oral hypoglycemic drugs and/or insulin treatment, or corticosteroid treatment within past 4 weeks
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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People's Liberation Army. The Military General Hospital of BeiJing

Beijing, , China

Site Status

Peiking University First Hospital

Beijing, , China

Site Status

Chinese PLA General Hospital

Beijing, , China

Site Status

The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University

Guangzhou, , China

Site Status

The Second Affiliated Hospital, Zhongshan (Sun Yat-sen) University

Guangzhou, , China

Site Status

Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University

Guangzhou, , China

Site Status

Countries

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China

References

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Gao HW, Xie C, Wang HN, Lin YJ, Hong TP. Beneficial metabolic effects of nateglinide versus acarbose in patients with newly-diagnosed type 2 diabetes. Acta Pharmacol Sin. 2007 Apr;28(4):534-9. doi: 10.1111/j.1745-7254.2007.00534.x.

Reference Type BACKGROUND
PMID: 17376293 (View on PubMed)

Other Identifiers

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CDJN608ACN06

Identifier Type: -

Identifier Source: org_study_id

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