Effect on glycernic control of the addition of 2.5 mg glipizide GITS to metformin in patients with T2DM

被引:35
作者
Feinglos, M
Dailey, G
Cefalu, W
Osei, K
Tayek, J
Canovatchel, W
Chaiken, R
Kourides, I
机构
[1] Duke Univ, Med Ctr, Div Endocrinol, Durham, NC 27710 USA
[2] Scripps Res Inst, La Jolla, CA USA
[3] Louisiana State Univ, Pennington Biomed Res Ctr, Baton Rouge, LA 70808 USA
[4] Ohio State Univ, Med Ctr, Div Endocrinol Diabet & Metab, Columbus, OH 43210 USA
[5] Univ Calif Los Angeles, Harbor Med Ctr, Torrance, CA 90509 USA
[6] Pfizer Inc, New York, NY USA
关键词
sulphonylurea; glipizide GITS; efficacy; add-on therapy; metformin;
D O I
10.1016/j.diabres.2004.09.002
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims: This study evaluated the effects on glycemic control of the addition of 2.5 mg glipizide GITS to metformin in patients with mild-to-moderate, but suboptimally controlled type 2 diabetes. Methods: In this multicenter, double-blind, placebo-controlled study, 122 patients with type 2 diabetes inadequately controlled (A(1c) 7-8.5%) on metformin (>= 1000 mg/day for >= 3 months) were randomized to 16 weeks treatment with 2.5 mg/day glipizide GITS (n = 61) or placebo (n = 61), in addition to their current metformin dose. The primary efficacy variable was the change in A,, from baseline to endpoint. Changes in fasting plasma glucose (FPG), insulin concentrations, lipid profile and safety variables were also measured. Results: The addition of glipizide GITS to metformin gave significantly greater improvements in mean A(1c) and FPG from baseline to endpoint than placebo addition (p < 0.0002). Significantly more patients in the glipizide GITS group than in the placebo group achieved the target A(1c) level of A(1c) < 7.0% (p < 0.0001) and an A(1c) < 6.5% (p < 0.0033). Fasting insulin concentrations were similar in both groups and unchanged by treatment. Addition of glipizide GITS to metformin did not produce any significant or clinically relevant weight gain or changes in BMI. Both treatment regimens were well tolerated. Conclusions: This study showed that the addition of 2.5 mg glipizide GITS to metformin significantly improved glucose control in patients with type 2 diabetes inadequately controlled by metformin monotherapy. (c) 2004 Elsevier Ireland Ltd. All rights reserved.
引用
收藏
页码:167 / 175
页数:9
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