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

Abstract 

Aims:

This study evaluated the effects on glycemic control of the addition of 2.5mg 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 (≥1000mg/day for ≥3 months) were randomized to 16 weeks treatment with 2.5mg/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_1c 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 2.5mg glipizide GITS to metformin significantly improved glucose control in patients with type 2 diabetes inadequately controlled by metformin monotherapy.

Abbreviations: ANOVA, analysis of variance, BMI, body mass index, CBC, clinical blood chemistry, FPG, fasting plasma glucose, GITS, gastrointestinal therapeutic system, HBGM, home blood glucose monitoring, HOMA, homeostasis model assessment, UKPDS, UK Prospective Diabetes Study

Keywords: Sulphonylurea, Glipizide GITS, Efficacy, Add-on therapy, Metformin