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Combination Therapy With Nateglinide and a Thiazolidinedione Improves Glycemic Control in Type 2 Diabetes

¹ Dallas Diabetes and Endocrine Center, Dallas, Texas
² Department of Clinical Reserch and Development, Novartis Pharmaceutical Corporation, East Hanover, New Jersey

OBJECTIVE—To compare the effects of monotherapy using nateglinide and the thiazolidinedione troglitazone with initial combination of the two agents on glycated hemoglobin (HbA_1c) in patients with type 2 diabetes inadequately controlled by diet alone.

RESEARCH DESIGN AND METHODS—This study consisted of a 28-week, double-blind, randomized, multicenter study that included a 4-week, single-blind, placebo, run-in period and a 24-week (shortened to 16 weeks), double-blind, active treatment period.

RESULTS—At the 16-week end point, nateglinide 120 mg, troglitazone 600 mg, and the combination of the agents achieved statistically significant decreases in HbA_1c in comparison with placebo and a baseline HbA_1c of 8.1–8.4% (P < 0.001). The reductions in HbA_1c were similar in the nateglinide (0.6%) and troglitazone (0.8%) monotherapy groups. The reduction in HbA_1c (1.7%) was greatest in the combination group; 79% of patients in the combination group achieved HbA_1c levels of <7%. The combination group had a higher number of adverse events, primarily due to an increased incidence of mild hypoglycemia in this treatment group.

CONCLUSIONS—Nateglinide and troglitazone are equally effective in decreasing HbA_1c levels. However, these reductions from baseline HbA_1c values of >8% are not adequate to achieve HbA_1c levels of <7%. In contrast, the combination of nateglinide and of a thiazolidinedione shows an additive effect that is highly effective in reducing HbA_1c levels to the target of <7% in 66% of patients, from a baseline HbA_1c that is just above 8%.

Abbreviations: LFT, liver function test

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