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

Inje University

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus

Treatments: Drug: nateglinide; Drug: acarbose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00437918

PDC-07-01

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)