NON INFERIORITY STUDY AND ANTI INFLAMMATORY EFFECT OF DPP-4 INHIBITORS IN TREATMENT NAÏVE TYPE 2 DIABETES MELLITUS PATIENTS

Naresh Bansal, S. K. Singh

Abstract


CONTEXT AND OBJECTIVES: The optimal management of hyperglycemia in type 2 diabetes patients remains an
elusive goal. The combination therapy with DPP-4 inhibitor plus other OAD’s is an attractive combination, getting more
patients to goal initially and avoiding or delaying the need for subsequent treatment regimen changes to maintain
glycemic goals. The pattern of response of DPP 4 inhibitors for glycemic end points and their tolerability is variable in
Indian population unlike that in other parts of world due to unique “Asian Indian Phenotype”. In this study, we evaluated
the efficacy and tolerability of combination DPP-4 inhibitor therapy in patients inadequately controlled with metformin
monotherapy in Indian patients with type 2 diabetes mellitus. The effect of DPP4 inhibitors in amelioration of the
inflammatory process was also studied by measurement of markers such as plasma C-reactive protein (CRP) and TNFα,
thus reflecting the improvement in end effects of chronic inflammation.
METHODS: This is an analysis of Indian patients who participated in 24 week, open labelled, randomized controlled
trial. Overall, 30 treatment naive type 2 diabetes patients were randomized to one of treatment regimens (Linagliptin 5
mg once daily [qd] + metformin 500/1000 mg [n = 15] or Other OAD + metformin 500/1000 mg [n = 15] and assessed at
12 and 24 wks.
RESULTS: As regards efficacy, DPP-4 inhibitor along with Metformin reduced fasting, postprandial plasma glucose and
HbA1c as that with other oral antidiabetic drugs (Glimeperide, Gliclazide and Pioglitazone) at 12 and 24 weeks. The
treatment with DPP-4 inhibitor was well tolerated without any specific adverse effects. In addition, there was reduction in
systemic inflammatory markers with DPP-4 inhibitors which was not noted with other oral antidiabetic drugs.
CONCLUSIONS: The DPP-4 inhibitors along with Metformin reduced fasting, postprandial glucose, HbA1c to a similar
degree without any adverse effects. Statistically significant reductions were obtained across wide range of T2DM patient
subgroups irrespective of baseline characteristics or β-cell function indices such as the homoeostatic model assessment
(HOMA)-β. The reduction of systemic inflammatory markers in type 2 diabetic patients’ independent of glycemic control
suggest potential role of DPP-4 inhibitors in cardiovascular protection


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