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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00437918
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : March 24, 2008
Information provided by:
Inje University

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Diabetes Mellitus Drug: nateglinide Drug: acarbose Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 7 point SMBG (self monitoring of blood glucose)

Secondary Outcome Measures :
  1. HOMA-beta for predicting the effectiveness of each agents

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00437918

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
Principal Investigator: Jeonghyun Park, MD PhD Director, Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jeong Hyun Park, MD PhD / Professor, Inje University Pusan Paik Hospital / Paik Diabetes Center Identifier: NCT00437918     History of Changes
Other Study ID Numbers: PDC-07-01
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: March 24, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs