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

Sponsor:	Inje University
Collaborator:	Sanofi-Aventis
Information provided by:	Inje University
ClinicalTrials.gov Identifier:	NCT00437918

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus Type 2 Diabetes Mellitus	Drug: nateglinide Drug: acarbose	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase IV Study on Predictive Markers for the Effectiveness of Nateglinide or Acarbose for Controlling Post-Prandial Glucose in Type 2 Diabetics Already on Optimized Insulin Glargine Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Acarbose A 4166

U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:

7 point SMBG (self monitoring of blood glucose) [ Designated as safety issue: No ]

Secondary Outcome Measures:

HOMA-beta for predicting the effectiveness of each agents [ Designated as safety issue: No ]

Enrollment:	85
Study Start Date:	January 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437918

Locations

Korea, Republic of
Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University
Busan, Korea, Republic of, 614-735
Endocrinology and Metabolism, Maryknoll General Hospital
Busan, Korea, Republic of

Sponsors and Collaborators

Inje University

Sanofi-Aventis

Investigators

Principal Investigator:

Jeonghyun Park, MD PhD

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

More Information

No publications provided by Inje University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Mar 3.

Responsible Party:	Jeong Hyun Park, MD PhD / Professor, Inje University Pusan Paik Hospital / Paik Diabetes Center
ClinicalTrials.gov Identifier:	NCT00437918 History of Changes
Other Study ID Numbers:	PDC-07-01
Study First Received:	February 20, 2007
Last Updated:	March 21, 2008
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose

Nateglinide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012