Repaglinide in type 2 diabetes: a 24-week, fixed-dose efficacy and safety study

Area of Science:

• Endocrinology
• Pharmacology
• Clinical Medicine

Background:

• Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder characterized by hyperglycemia.
• Effective glycemic control is crucial for preventing long-term diabetic complications.
• Repaglinide is an oral glucose-lowering agent that stimulates insulin secretion.

Purpose of the Study:

• To evaluate the efficacy and tolerability of fixed-dose, preprandial repaglinide in patients with type 2 diabetes.
• To compare the effects of repaglinide 1 mg and 4 mg against placebo on glycemic parameters.

Main Methods:

• A 24-week, multicenter, double-blind, randomized, fixed-dose trial.
• 361 patients with type 2 diabetes were randomized to placebo, repaglinide 1 mg, or repaglinide 4 mg daily before meals.
• Glycemic control was assessed by fasting plasma glucose (FPG) and HbA1c levels.

Main Results:

• Repaglinide 1 mg and 4 mg significantly reduced mean FPG by -47 mg/dL and -49 mg/dL, respectively, compared to a 19 mg/dL increase with placebo.
• HbA1c levels were 1.8–1.9 percentage points lower in repaglinide groups versus placebo at study end.
• No severe hypoglycemia events occurred; most symptomatic episodes had glucose >45 mg/dL.

Conclusions:

• Fixed-dose, preprandial repaglinide (1 mg or 4 mg) is an effective treatment for improving glycemic control in type 2 diabetes.
• Repaglinide demonstrated a favorable safety profile with minimal risk of severe hypoglycemia.
• The treatment was well-tolerated and effective without dose adjustment based on clinical parameters.