Repaglinide Found To Be Effective And Flexible Theraphy In Treating Type 2 Diabetes - Brief Article

Nutrition Research Newsletter, Feb, 2001

Repaglinide is a new insulin secretagogue developed for treating type 2 diabetes mellitus. It is intended to have a flexible mealtime dosage regimen. When given immediately prior to a meal, it has been shown to augment insulin secretion within the first thirty minutes of starting a meal and has little to no detectable secretagogue activity four hours later. This approach is beneficial as it addresses the primary problem in type 2 diabetes--the progressive loss of the early phase prandial insulin response. To date, all research on this drug uses fixed dose and mealtime regimens.

A study reported in Diabetes Care set out to assess whether the efficacy and safety of repaglinide shown in fixed-dose, fixed-meal environment would be carried over when patients were free to vary their number and timing of meals. A double-blind randomized placebo-controlled parallel group trial was performed at 61 centers in 13 different countries. Patients with type 2 diabetes who were suboptimally diet-controlled served as subjects. Subjects included both men and women older than 40 years of age. Patients who had previously received an oral diabetic agent were excluded. The subjects also had no significant hepatic disease, cardiovascular disease, or other diabetic complications. In the study, 349 subjects received either 0.5 mg of repaglinide at mealtimes or placebo. One tablet was taken before each main meal. Subjects were free to eat as many meals, and therefore take as many repaglinide or placebo meals as their schedules warranted. The dose of repaglinide was doubled after four weeks if fasting plasma glucose exceeded 7.8 [micro]mol/l. Glycemic control was assessed using [HbA.sub.1c] and fasting plasma glucose (FPG) at the screening visit, after four weeks and after a further 12 weeks. Weight, blood pressure, and clinical laboratory values were recorded at baseline and after four and 12 weeks. Quality-of-life questionnaires were also evaluated and reported elsewhere. All adverse events, including severe hypoglycemia, were recorded whether they were observed by the investigator or reported by the patient.

Treatment with repaglinide was found to significantly improve glycemic control over baseline as evidenced by reducing [HbA.sub.1c] by 1.14% from baseline and fasting plasma glucose by 1.8 [micro]mol/l. This observed improvement was independent of the meal pattern. The improvement in glycemic control was also independent of the degree of obesity and no significant change in body weight was observed with either repaglinide or placebo.

Researchers conclude that repaglinide is effective in improving overall glycemic control in patients with type 2 diabetes who are not well controlled on diet alone. This medication is flexible as it allows patients to vary their meal patterns from a conventional regimen with little apparent side effects.

R. Moses, R. Gomis, K. Frandsen, et al. Flexible meal-related dosing with repaglinide facilitates glycemic control in therapy-naive type 2 diabetes. Diabetes Care 24:11-15 (January 2001) [Correspondence: Dr. Robert Moses, Wollongong Diabetes Service, Ste. 4, 393 Crown St., Wollongong 2500, NSW, Australia. E-mail: robert_moses@uow.edu.au].