Glycemic control and variability of blood glucose in patients with type 2 diabetes mellitus managed with sulfonylureas, the DPP -4-inhibitors

• O.O. Popova

Abstract

Objective: to assess the glycemic control and variability of daily blood glucose of low-dose DPP-4 inhibitor saxagliptin and sulfonylurea (gliclazide) as add-on therapy to metformin in patients with inadequate glycemic control with metformin alone and saxagliptin add-on therapy to glibenclamide.

Materials and Methods: The study included 86 patients of middle age (49–62): 53 women and 34 men. The patients were randomized to receive metformin and saxagliptin – 29 people, metformin and gliclazide – 27 people, a group of combination therapy saxagliptin with sulfonylurea – 28. The evaluation of the variability of daily glycemia was compiled using CGMS: average blood glucose for 3 days, duration of the period of normoglycemia, hyperglycemia, hypoglycemia for 3 days, the variability of glucose. Patients were examined with continuous glucose monitoring system - CGMS, evaluation of glycated hemoglobin (HBA1c), fasting plasma glucose (FPG) and postprandial plasma glucose (PPG).

Results: The results of this trial demonstrated the efficacy of saxagliptin or gliclazide add-on therapy to metformin in patients with inadequate glycemic control with metformin alone and the possibility of effective saxagliptin add-on therapy to glibenclamide. In 3 months, 48.1 % of pa-tients achieved the target of glycaemic control in the saxagliptin + metformin group and 50 % in the metformin + gliclazide , 49,2 % in the saxagliptin + glibenclamide, reductions from baseline in HbA1c were: -0,65 % for saxagliptin+metformon and -0.69 % for gliclazide+metformin, -0,68 % for saxagliptin+glibenclamide; the period of normoglycemia increased and prevail over a period of hyperglycemia in 78 % of patients who used saxagliptin+metformin and 60 % of patients with gliclazide+metformin, 74% in saxagliptin+glibenclamide group. It was no incidence of confirmed hypoglycemia in saxagliptin + metformin group, confirmed hypoglycemia was reported of patients in the gliclazide + metformin group and glibenclamide + saxagliptin in 15% and 24 % respectively. CGMS data confirmed reduction of the minimum and maximum values of glucose in patients with saxagliptin add-on therapy to metformin.

Conclusions: saxagliptin add-on therapy is comparable with gliclazide add-on to metformin in patients with inadequate glycemic control on stable dose of metformin alone. Saxagliptin im-proves glycemic control with an increase in insulin secretion and suppression of glucagon secre-tion in a glucose-depended fashion, and this effect is confirmed by a positive impact on glycemia variability characteristic. Saxagliptin add-on therapy was associated with lower risk of hypogly-cemia. Saxagliptin add-on treatment improve glycemic parameters and increase the efficacy of achieving glycemic goal in patients who fail on metformin monotherapy without increasing side effects and very low propensity of hypoglycemia. Saxagliptin can be coadministered with glibenclamide. This therapy demonstrate reductions in glycemic parameters (HBA1c, FPG, PPG), but it is necessary to take into consideration higher risk of hypoglycemia.

Keywords:type 2 diabetes mellitus, combination therapy, glycemic variability

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