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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: nateglinide
• Drug: acarbose

Primary Measures

• 7 point SMBG (self monitoring of blood glucose)
  • Safety Issue?: No

Secondary Measures

• HOMA-beta for predicting the effectiveness of each agents
  • Safety Issue?: 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Inje University

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00437918

Study ID Number: PDC-07-01

ClinicalTrials.gov Identifier: NCT00437918

Health Authority: Korea: Food and Drug Administration