Discussion
flatulence, diarrhea, abdominal pain, TIR, hypoglycemia, hyperglycemia, reduced fasting blood lipids, ’ blood glucose, abdominal distension, postprandial hyperglycemia, T2DM, diabetes
HYPERLIPIDEMIA, ASYMPTOMATIC HYPOGLYCEMIA, HYPOGLYCEMIA, HYPERGLYCEMIA, DIABETIC COMPLICATIONS, DIABETES
It is important to reach the target levels for blood glucose and HbA1c when treating patients with T2DM. Good control over blood glucose fluctuations is also important. Patients with diabetes who have similar HbA1c levels may have different blood glucose stabilities, and large blood glucose fluctuations may be associated with a greater risk of diabetic complications (In this study, the three treatment regimens all improved the patients’ blood glucose levels, and the results in the Ins+SZ-A group were superior to those in the Ins+Met and Ins groups in terms of improving postprandial blood glucose fluctuations. All three treatment regimens reduced fasting blood lipids, but the Ins+Met and Ins+SZ-A treatments also improved the patients’ postprandial blood lipid indicators.HbA1c, which reflects long-term blood glucose control, has become the gold standard for evaluating blood glucose control and guiding clinical decisions regarding the management of diabetes. Compared to during the screening period, the HbA1c and FBG levels in all three groups decreased following the 12-week treatment period. After 12 weeks treatment, the HbA1c, FBG, and administered insulin doses in the Ins+Met and Ins+SZ-A groups were lower than those in the Ins group. The insulin doses in the Ins+Met and Ins+SZ-A groups during the lead-in period were 29.00 (24.00, 34.5) and 32.00 (20.50, 33.25), respectively. Following the 12-week treatment period, these doses decreased to 19.00 (15.50, 28.50) and 21.00 (18.50, 30.50), respectively. Although the absolute values of insulin doses in the Ins+SZ-A group were greater than those in the Ins+Met group, both during the lead-in period and after 12 weeks of treatment, this difference was not statistically significant. Therefore, we believe that drugs, rather than insulin, decrease hypoglycemia and hyperlipidemia.TIR is a key CGM indicator that describes short-term blood glucose control and quantifies the time within the target range (MBG reflects the average blood glucose level, whereas SDBG reflects the magnitude of overall deviations in glucose levels from the average (LAGE is the difference between the maximum and minimum daily glucose levels, and may be an independent predictor of nocturnal asymptomatic hypoglycemia in patients with T2DM. LAGE measurements of >3.48 mmol/L can be used as an early warning sign of nocturnal asymptomatic hypoglycemia (MODD reflects day-to-day blood glucose excursions, which are the differences between blood glucose values measured at the same time point on two consecutive days. The MODDs of all three groups in our study cohort were lower during the lead-in period than during the screening period. There were no statistically significant differences observed in terms of MODDs among the three groups during the lead-in period or after 12-week treatment period.Postprandial blood glucose control is crucial for achieving overall blood glucose control, with postprandial hyperglycemia being the main factor that leads to general hyperglycemia (After the 12 weeks of treatment, the dinner AUCpp of the Ins+SZ-A group was lower than that of the Ins+Met and Ins groups, indicating that the Ins+SZ-A group experienced a more significant improvement in post-dinner blood glucose levels, which may be partially due to the cumulative effect of α-glucosidase inhibitors (Animal experiments have shown that SZ-A significantly reduces liver weight, liver triglycerides, and total cholesterol levels. However, there is still no data regarding the effects of SZ-A on postprandial blood lipids (Gastrointestinal side effects are one of the limitations to the clinical application of α-glycosidase inhibitors and Met. These may include flatulence, abdominal distension, diarrhea, abdominal pain, and other symptoms. In our experiment, the incidence of GDs in the Ins+SZ-A group was very low. To the best of our knowledge, this is the first research to evaluate the effects of SZ-A or Met combined with premixed insulin on blood glucose fluctuations in patients with T2DM. The combination of SZ-A or Met with premixed insulin not only improved blood glucose control, but also reduced blood glucose fluctuations and blood lipid indicators in our cohort of patients with T2DM whose blood glucose levels could not be controlled through the use of oral medications. SZ-A combined with premixed insulin proved to be better for reducing postprandial blood glucose fluctuations than Met combined with premixed insulin and premixed insulin alone. However, this study also had some limitations worth noting. This was a single-center study with a relatively small number of patients and a study period of only 3 months. Thus, it would be best to extend the treatment period to 6 months or 1 year. Further multi-center studies with larger sample sizes are also warranted to evaluate the safety and efficacy of long-term treatment with SZ-A.The results of this study suggest that the combination of SZ-A and Met with premixed insulin is a potential treatment option for patients with T2DM whose blood glucose levels cannot be adequately controlled by oral medications, and SZ-A combined with premixed insulin may be more suitable for Chinese patients who consume higher levels of carbohydrates. Further prospective studies with more patients over longer periods are required to verify this hypothesis.