The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients

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

PHASE4

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-03-31

Brief Summary

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In type 2 diabetic patients, tight blood glucose control often requires both fasting and post-prandial glucose control separately. In the diabetic patients already on the insulin glargine treatment for the control of fasting blood glucose, additional measures for the control of post-prandial glucose level are often required. Nateglinide and acarbose are frequently used for this purpose. We hypothesized that the short acting sulfonylurea "nateglinide" may be more efficacious in diabetic patients with appreciable endogenous insulin secretion, while acarbose may be more efficacious in patients with lower endogenous insulin secretion. And we also want to clarify the clinical and biochemical parameters that can predict the responsiveness to each agent in this multi-center randomized open cross-over clinical study.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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nateglinide

Intervention Type DRUG

acarbose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Korean
* Type 2 diabetes mellitus
* No prior history of diabetic ketoacidosis
* HbA1c between 7.5-10.0%

Exclusion Criteria

* Type 1 diabetes mellitus
* Gestational diabetes mellitus
* Secondary diabetes mellitus
* Severe hyperglycemia with symptoms
* Severe chronic diabetic complications (PDR,s-Cr\>1.3mg/dL)

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Inje University Pusan Paik Hospital / Paik Diabetes Center

Principal Investigators

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Jeonghyun Park, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Director, Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University

Locations

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Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University

Busan, , South Korea

Site Status

Endocrinology and Metabolism, Maryknoll General Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

References

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Kim MK, Suk JH, Kwon MJ, Chung HS, Yoon CS, Jun HJ, Ko JH, Kim TK, Lee SH, Oh MK, Rhee BD, Park JH. Nateglinide and acarbose for postprandial glucose control after optimizing fasting glucose with insulin glargine in patients with type 2 diabetes. Diabetes Res Clin Pract. 2011 Jun;92(3):322-8. doi: 10.1016/j.diabres.2011.01.022. Epub 2011 Mar 3.

Reference Type DERIVED

PMID: 21376417 (View on PubMed)

Other Identifiers

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PDC-07-01

Identifier Type: -

Identifier Source: org_study_id