Combined hypoglycemic therapy: iDPP-4 in comparison with sulfonylureas

• Alexander S. Ametov
• Butaeva S.G.

Abstract

Aim. To evaluate the effectiveness and safety of treatment intensification with sitagliptinvs, glyclazide in type 2 diabetes patients who did not achieve the glycaemiсtargets on metformin mono.

Material and methods. 51 patients (mean age 58.06±8.33 y.o.) with type 2 DM uncontrolled (HbA_1c 7.92±0.47%) on metformin mono (2000 mg/day) were included. In the course of randomization, 2 groups were formed: 1^st group patients were intensified by 100 mg/day of sitagliptin, the 2^nd group patients - by gliclazide 60 mg/day. Initially, after 3 and 12 weeks of therapy, the parameters of carbohydrate metabolism were assessed: fasting plasma glucose, postprandial glycemia, glycated hemoglobin, and continuous monitoring of glycemia with the calculation of glycemic variability parameters.

Results. After 12 weeks, the HbA_1c level showed a significant decrease: in the 1^st group from 7.91±0.44 to 6.42±0.69% (p<0.001), in the 2^nd group from 7, 93±0.5 to 6.54±0.73% (p<0.001). The level of FBG in the 1^st group changed from 7.78±2.36 mmol/l to 6.03±0.88 (p<0.001); in the 2^nd group from 7.80±1.93 mmol/l, initially to 6.76±0.85 mmol/l, PPG in the 1^st group decreased from 9.84±2.39 to 7.21±1.0 mmol/L (-26.72%, p<0.001); in the 2^nd group from 10.03±1.99 to 8.03±1.32 mmol/l (p<0.001). The level of mean ampli­tude glucose excurtions (MAGE) in the 1^st group underwent significant changes from 3.05±1.10 to 2.26± 0.68 mmol/l (p<0.001), in the 2^nd group changes have not reached reliable values. The standard deviation in both study groups did not change significantly after the study was completed. The stay of patients in the state of hyperglycemia in 1^st group significantly changed as follows: 60.20±27.21% initially, 12.36±10.90% at the end of the study (p<0.001). In the 2^nd group: from 62.42±19.72 to 17.11±12.37% (p<0.001). The pres­ence in normoglycemia in the 1^st group increased from 39.72±27.31 to 87.32 ± 10.79% (p<0.001); in the 2^nd: from 37.92±20.29 to 79.46±16.33% (p<0.001). Not a single severe hypoglycemic condition was detected. Weight changes in the 1^st group had the following dynamics: -1.71 kg, 1.80% of the initial; p<0.01 at the stage of 12 weeks of therapy. In 2^nd group, there were no significant changes in weight fluctuations. The waist circumference in the 1^st group decreased by 5.13% compared to the beginning of the study and was 98.96±23.84 cm. In the 2^nd group, no significant changes in the circumference of the waist were observed (p=1.0).

Conclusions. In both treatment groups, combined therapy contributed to the safe and effective control of glycemia.

Keywords:diabetes mellitus type 2, sitagliptin, glyclazide, continuous monitoring of glycemia

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