| خلاصه مقاله | Background:
The study aimed to measure the effectiveness and safety of adding sitagliptin to insulin/ metformin regimes in overweight and obese cases with moderately controlled type 2 diabetes mellitus (T2DM).
Material and Methods:
In a 12-week, randomized, controlled clinical trial, overweight/obese cases with T2DM were randomly assigned to provide either a placebo (n=30) or sitagliptin 100 mg once a day (n=30) in about 12 weeks. The main endpoints were the measurement of glycosylated hemoglobin (HbA1c %), fasting plasma glucose (FPG)(mg/dL), 2-hour post-meal glucose (PMG), and lipid profile. The safety of sitagliptin was assessed as a secondary endpoint.
Results:
The average changes from baseline of FPG, 2-hour PMG, HbA1C, and BMI were noticeably declined in the sitagliptin group compared to the placebo group (P<0.001). Furthermore, the changes in low-density lipoprotein (LDL-c) were noticeably lesser in the sitagliptin arm compared to the placebo arm after adjusting for confounding factors (P=0.011). The outbreak of harmful effects, hypoglycemia, urinary and genital infection, and hypovolemia did not differ among groups (P>0.05).
Conclusion:
Sitagliptin with insulin/metformin treatment gives rise to better augmentation in glycemic and lipid profiles without weight gain and hypoglycemic effects in overweight and obese Iranian populations with inadequate diabetes control. The favorable impacts of sitagliptin on lipid profiles, amelioration in glycemic indices, and decrement in BMI suggest that sitagliptin is a safe medication for cardiovascular happenings, which is an important issue in the production of antidiabetic pharmaceutics. |