The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients
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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 4 |
| 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 |
- 7 point SMBG (self monitoring of blood glucose) [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| 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):
| 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 May 16, 2013