A novel fixed-dose combination tablet of repaglinide plus metformin provides comparable glycemic control to a rosiglitazone plus metformin tablet, show results from a phase III study.

Combining oral agents into fixed-dose combination tablets offers potential increased convenience for patients and increased compliance with therapy.

Philip Raskin (University of Texas Southwestern Medical Center, Dallas, Texas, USA) and colleagues compared the efficacy and safety of the recently-approved repaglinide/metformin fixed-dose combination tablet with an existing rosiglitazone/metformin formulation.

In the 26-week study, 561 individuals with Type 2 diabetes not adequately controlled with mono- or dual oral antidiabetes medication were randomized in a 1:1:1 fashion to a repaglinide/metformin fixed-dose combination tablet either twice, or three times daily, or a rosiglitazone/metformin fixed-dose combination tablet twice daily.

The study was designed to test primarily whether treatment with the repaglinide/metformin single-tablet combination is noninferior to treatment with a rosiglitazone/metformin tablet as measured by changes in glycated hemoglobin (HbA1c), and secondly that treatment with repaglinide/metformin twice daily is noninferior to three times daily treatment.

“The repaglinide/metformin fixed-dose combination was shown here to be noninferior to rosiglitazone/metformin,” report the authors in the journal Diabetes, Obesity and Metabolism.

Final changes in HbA1c were not significantly different between the repaglinide/metformin and the rosiglitazone/metformin treatment arms, although reductions were observed earlier with repaglinide/metformin.

In contrast, rosiglitazone/metformin showed significantly greater reductions in fasting plasma glucose at weeks 18 and 26 than repaglinide/metformin.

The authors attribute this observation to the mechanisms of action of the two compounds. An insulin sensitizer such as rosiglitazone is more likely to improve fasting plasma glucose levels, whereas an insulin secretagogue such as repaglinide taken at mealtime is more likely to improve postprandial glucose excursions.

Rosiglitazone/metformin had a mostly adverse effect on lipid profiles. Triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein (HDL) cholesterol and non-HDL cholesterol all increased in this group, while the same parameters all decreased or were essentially unchanged during treatment with repaglinide/metformin.

As expected, hypoglycemic episodes were more frequent with repaglinide/metformin than rosiglitazone/metformin (38.8% vs 10.2%, respectively), although there were no episodes of severe hypoglycemia.

In the rosiglitazone/metformin group, peripheral edema was reported in 6.5% of individuals, but in only 2.1% of individuals in the repaglinide/metformin group. Overall adverse event profiles were comparable between treatment groups.

“This new repaglinide/metformin fixed-dose combination twice daily had efficacy comparable to that of the rosiglitazone/metformin fixed-dose combination twice daily currently in clinical use,” conclude the authors.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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