Efficacy and safety of vildagliptin, sitagliptin, and linagliptin as add-on therapy in Chinese patients with T2DM inadequately controlled with dual combination of insulin and traditional oral hypoglycemic agent

Abstract

ObjectiveWe aimed to evaluate the efficacy and safety of the three dipeptidyl peptidase 4 (DPP-4) inhibitors (vildagliptin, sitagliptin, and linagliptin) as add-on therapy in Chinese patients with type 2 diabetes mellitus (T2DM)inadequately controlled on dual combination of insulin and metformin or acarbose.MethodsA total of 535 T2DM patients who failed to achieve glycemic control with insulin and a traditional oral hypoglycemic agent were randomized to receive vildagliptin, sitagliptin, or linagliptin. Body mass index, glycosylated hemoglobin (HbA1c), fasting and postprandial plasma glucose (FPG and PPG), insulin dose, and adverse events were evaluated during the study.ResultsThe baseline HbA1c was 9.59 ± 1.84 % (vildagliptin group), 9.22 ± 1.60 % (sitagliptin group), and 9.58 ± 1.80 % (linagliptin group). At week 12 it was 8.16 ± 1.29 % (vildagliptin), 8.56 ± 1.96 % (linagliptin), and 8.26 ± 1.10 % (sitagliptin). The changes in HbA1c from baseline were −1.33 ± 0.11 % (vildagliptin), −0.84 ± 0.08 % (sitagliptin) and −0.81 ± 0.08 % (linagliptin), the vildagliptin group had the greatest reduction in HbA1c (P < 0.05). The proportions of patients that reached target HbA1c were 66.27 % (vildagliptin), 52.73 % (sitagliptin), and 55.49 % (linagliptin), the vildagliptin group had the highest one (P < 0.05). The baseline FPG and PPG values in the three groups were at the same level. At week 12, mean FPG levels in the vildagliptin (7.31 ± 1.50 mmol/L) and linagliptin (6.90 ± 1.55 mmol/L) groups were significantly lower than in the sitagliptin group (8.02 ± 4.48 mmol/L; P < 0.05); the linagliptin group had the lowest mean PPG followed by the vildagliptin group which was also significant lower (P = 0.000) than the sitagliptin group. Additionally, the required insulin dosage in the vildagliptin group was the lowest among the groups at weeks 6 and 12. Only mild AEs were reported during the study.ConclusionThe three DPP-4 inhibitors appear to be effective and safe as add-on therapy for T2DM patients on dual combination of insulin and a traditional OHA. Vildagliptin was more effective in decreasing insulin requirement and achieving glycemic control when compared to the other two.

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“…The complex etiology of T2D and the clinical diversity among patients have led to the use of combinations of some of these drugs, together with lifestyle changes regarding diet and exercise . However, many of the most commonly used drugs have several side effects .…”

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“…Although there are some reports comparing the hypoglycemic effect of the different classes of DPP-4 inhibitors in patients with type 2 diabetes mellitus (T2DM) [3][4][5][6], efficacy of different DPP-4 inhibitors on glycemic control was not the same from one report to another. Furthermore, serum levels of active glucagon-like peptide-1 (aGLP-1), or C-peptide, which are the direct or indirect targets of DPP-4 inhibitor, have not been reported.…”

Management of type 2 diabetes mellitus: insights into prescribing trends

“…3 Although monotherapies can provide initial glycemic control, they have failed to demonstrate effectiveness in maintaining long-term glycemic control because of progressive deterioration of β-cell function. 1,4 This inability of monotherapy to maintain good glycemic control in T2DM provides the rationale for the early use of combination therapy with different classes of drugs. 4 Combination therapy imparts various advantages such as lower doses than those required for individual monotherapies, reduction in adverse effects associated with higher doses of monotherapy and thus improved tolerability.…”

“…1,4 This inability of monotherapy to maintain good glycemic control in T2DM provides the rationale for the early use of combination therapy with different classes of drugs. 4 Combination therapy imparts various advantages such as lower doses than those required for individual monotherapies, reduction in adverse effects associated with higher doses of monotherapy and thus improved tolerability. 4 Previous EDGE study has shown that in a 'real-life' setting, vildagliptin can lower HbA1c to target more frequently than comparator oral hypoglycemic agents (OHA) with better safety profile.…”

“…4 Combination therapy imparts various advantages such as lower doses than those required for individual monotherapies, reduction in adverse effects associated with higher doses of monotherapy and thus improved tolerability. 4 Previous EDGE study has shown that in a 'real-life' setting, vildagliptin can lower HbA1c to target more frequently than comparator oral hypoglycemic agents (OHA) with better safety profile. 5 However, there is no clarity on which particular class of OHA to be preferred in patients uncontrolled on metformin and which particular drug be selected amongst the class for varying groups of patient population.…”