Fixed combination sitagliptine-metformin (Janumet®) in the treatment of type 2 diabetic patients with high cardiovascular risk

• S.V. Nedogoda
• Irina N. Barykina
• Alla S. Salasyuk
• V.O. Smirnova

Abstract

Background. The management of T2DM requires aggressive treatment to achieve glycemic and cardiovascular risk factor goals. Patients with small duration of the disease is preferable to use drugs that have not exhausting, but rather a protective effect on the function of pancreatic β-cells. The complementary hypoglycemic properties of well-known metformin with sitagliptin make fixed dose combination treatment an attractive prospect. Therapy can be administered separately or by using a fixed combination, which should improve drug compliance. Overall, the combination use of this combination is an attractive option for clinicians to use in the treatment of type 2 diabetes with high cardiovascular risk due to the cardioprotective effects of incretins.

Methods. It was a prospective, open-label study. 90 patients with DM type 2 and high cardiovascular risk were enrolled. All patients before enrollment received sulfonylureas and have not reached a satisfactory glycemic control. After inclusion in the study, all patients were switched to sitagliptin/metformin fixed combination (Janumet) for 24 weeks. The primary endpoint of the study was change in fasting and postprandial blood glucose, HbA1c, lipid profile and C-peptide levels from baseline to study end. BP, arterial stiffness, BMI, uric acid, creatinine, ALT, AST were also investigated.

Results. At the end, mean percentage of fall in HbA1c and FBG from baseline with sitagliptin/metformin reflected the effectiveness of this therapy in achieving glycemic goals. C-peptide levels increased after 24 weeks of therapy, which is a consequence of the protective action of this combination on the function of pancreatic β-cells. There were no serious adverse events, including hypoglycemia and predefined gastrointestinal AEs were reported during therapy.

Conclusion. Sitagliptin/metformin fixed combination is well tolerated and effective in patients with high cardiovascular risk and uncontrolled hyperglycemia on sulfonylureas therapy. In addition to effective glycemic control, this combination has a significant cardioprotective effect, which is particularly important for this category of patients.

Keywords:incretin, metformin, sitagliptin, sulfonylureas, blood glucose, diabetes mellitus type 2, dipeptidyl-peptidase IV inhibitors, fixed combination

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