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

Phase 4
Completed
Conditions
Diabetes Mellitus
Type 2 Diabetes Mellitus
Registration Number
NCT00437918
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
85
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
7 point SMBG (self monitoring of blood glucose)
Secondary Outcome Measures
NameTimeMethod
HOMA-beta for predicting the effectiveness of each agents

Trial Locations

Locations (2)

Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University

🇰🇷

Busan, Korea, Republic of

Endocrinology and Metabolism, Maryknoll General Hospital

🇰🇷

Busan, Korea, Republic of

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