Insulin glargine effectively achieves glycemic control and improves insulin resistance in patients with early type 2 diabetes that exhibit a high risk for cardiovascular disease

Abstract

In the present study, the clinical efficacy and safety of administering insulin glargine to early type 2 diabetes (T2D) mellitus patients with a high risk for cardiovascular disease were assessed. A total of 42 early T2D patients at a high risk for cardiovascular disease were randomly divided into an insulin-glargine group and a standard-care group. The patients in the insulin-glargine group received oral antidiabetic agents plus glargine once a day via a subcutaneous injection. The patients in the standard-care group were administered oral antidiabetic agents according to the diabetic treatment guidelines. The median follow-up period was 6.4 years. Comparisons were made between the two groups with regard to levels of plasma glucose, glycosylated hemoglobin (HbA1c) and plasma lipids, the homeostasis model assessment-insulin secretion index (HOMA-β) and HOMA-insulin resistance index (HOMA-IR), as well as the incidence of hypoglycemia, adverse cardiovascular events and body mass index (BMI). The fasting plasma glucose level in the insulin-glargine group was significantly lower than that observed in the standard-care group. However, the levels of 2-h postprandial glucose, HbA1c and plasma lipids, as well as the BMI, were similar when comparing the two groups. Although the level of the HOMA-β did not differ between the two groups, the level of HOMA-IR in the insulin-glargine group was significantly lower than that observed in the standard-care group. During the follow-up period, the incidence of hypoglycemia in the insulin-glargine group was significantly higher when compared with the standard-care group, however, no significant difference in the incidence of adverse cardiovascular events was observed. Therefore, the results of the present study indicated that insulin glargine may effectively achieve glycemic control and improve insulin resistance without increasing the risk for cardiovascular events in early T2D patients that were considered to be at a high risk for cardiovascular disease.

Keywords: cardiovascular risk; glycemic control; insulin glargine; insulin resistance; type 2 diabetes mellitus.

Figure 1

Changes in the FPG level. Outpatients were followed-up every 3–6 months to determine the FPG levels using a glucose oxidase assay. Following treatment, the mean FPG level in the insulin-glargine group demonstrated a constant overall reduction from 7.07 to 5.79 mmol/l (P<0.01) during the 6.4-year treatment period. The FPG level in the insulin-glargine group was significantly lower than that observed in the standard-care group during the follow-up period. ^*P<0.05, vs. standard-care group. FPG, fasting plasma glucose.

Figure 2

Changes in the HbA1c level. Outpatients were followed-up every 3–6 months to assess the HbA1c levels using high performance liquid chromatography. Following treatment, the mean HbA1c level in the insulin-glargine group did not significantly change during the 6.4-year treatment period. In addition, the levels of HbA1c did not differ between the two groups. HbA1c, glycosylated hemoglobin.

Figure 3

Changes in the FPG levels in the two groups between the baseline and the study endpoint. FPG levels were determined at the beginning of the study and at the final follow-up examination using a glucose oxidase assay. The mean FPG level in the insulin-glargine group changed significantly between the baseline and the endpoint. ^*P<0.01, vs. baseline; ^#P<0.05, vs. standard-care group. FPG, fasting plasma glucose.