The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients
Information source: Inje University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Type 2 Diabetes Mellitus
Intervention: nateglinide (Drug); acarbose (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Inje University Official(s) and/or principal investigator(s):
Jeonghyun Park, MD PhD, Principal Investigator, Affiliation: Director, Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
Primary outcome: 7 point SMBG (self monitoring of blood glucose)
Secondary outcome: HOMA-beta for predicting the effectiveness of each agents
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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)
Locations and Contacts
Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University, Busan 614-735, Korea, Republic of
Endocrinology and Metabolism, Maryknoll General Hospital, Busan, Korea, Republic of
Additional Information
Starting date: January 2007
Ending date: March 2008
Last updated: March 21, 2008
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