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Nateglinide, alone or in combination with metformin, is effective and well tolerated in treatment‐naïve elderly patients with type 2 diabetes
Author(s) -
Schwarz S. L.,
Gerich J. E.,
Marcellari A.,
JeanLouis L.,
Purkayastha D.,
Baron M. A.
Publication year - 2008
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2007.00792.x
Subject(s) - nateglinide , metformin , medicine , type 2 diabetes , placebo , tolerability , postprandial , discontinuation , gastroenterology , diabetes mellitus , randomized controlled trial , pharmacology , adverse effect , endocrinology , alternative medicine , pathology
Aim: The aim of this work was to assess the efficacy and tolerability of nateglinide alone or in combination with metformin in elderly patients with type 2 diabetes (T2DM). Methods: Study 1 was a 12‐week, multicentre, randomized, double blind and placebo‐controlled study of nateglinide monotherapy (120 mg, before meals) in 66 drug‐naïve patients with T2DM aged ≥65 years. Study 2 was a 104‐week, multicentre, randomized, double blind and active‐controlled study of nateglinide (120 mg, before meals) or glyburide (up to 5 mg bid) in combination with metformin (up to 1000 mg bid) in 69 treatment‐naïve patients with T2DM aged ≥65 years. HbA 1c , fasting and postprandial glucose levels, and safety assessments were made. Results: In Study 1, nateglinide significantly reduced HbA 1c from baseline (7.6 ± 0.1% to 6.9 ± 0.1%; Δ = −0.7 ± 0.1%, p < 0.001) and compared with placebo (between‐group difference = −0.5%, p = 0.004 vs. nateglinide). No hypoglycaemia was reported. In Study 2, combination therapy with nateglinide/metformin significantly reduced HbA 1c from baseline (7.8 ± 0.2% to 6.6 ± 0.1%; Δ = −1.2 ± 0.2%, p < 0.001), as did glyburide/metformin (7.7 ± 0.1% to 6.5 ± 0.1%; Δ = −1.2 ± 0.1%, p < 0.001). There was no difference between treatments (p = 0.310). One nateglinide/metformin‐treated patient experienced a mild hypoglycaemic episode compared with eight episodes in eight patients on glyburide/metformin; one severe episode led to discontinuation. Target HbA 1c (<7.0%) was achieved by 60% of patients receiving nateglinide (Study 1) and 70% of nateglinide/metformin‐treated patients (Study 2). Conclusion: Initial drug treatment with nateglinide, alone or in combination with metformin, is well tolerated and produces clinically meaningful improvements in glycaemic control in elderly patients with T2DM.