The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: March 2008
Intervention(s) in this Clinical Trial
- Drug: nateglinide
- Drug: acarbose
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Inje University Other
Overall Clinical Trial Officials and Contacts
Jeonghyun Park, MD PhD Principal Investigator Director, Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00437918
