Open-label, randomized, multiple-center, parallel study comparing glycemic responses and safety profiles of Glucerna versus Fresubin in subjects of type 2 diabetes mellitus

Abstract

Since the increase of prevalence of type 2 diabetes mellitus (T-2DM), the replacing quickly absorbed carbohydrates with a fat source rich in monounsaturated fatty acid to provide improved glycemic control in these patients has become an important assistant therapy. In the present study, we compared glycemic response and safety of two nutritional products, Glucerna and Fresubin, in Chinese subjects with T-2DM. Overall, 203 T-2DM subjects were randomly assigned (1:1) to either Glucerna or Fresubin. The primary endpoint was the adjusted area under the curve (adj-AUC) for plasma glucose at 0-240 min. Blood samples were collected at 0, 30, 60, 90, 120, 180, and 240 min to compare the adjusted area under the curve (AUC) for the change in plasma glucose or insulin from 0 to 240 min. Adjusted peak values and times of glucose and insulin responses and adjusted glucose and insulin values were collected at the same time points. Safety parameters were also evaluated. The adjusted AUC for the change in plasma glucose in the Glucerna group was significantly lower than in Fresubin group (5.60 +/- 5.88 mmol/l*h vs. 7.97 +/- 6.32 mmol/l*h, P = 0.0061), as was the adjusted peak value of glucose (3.51 +/- 2.04 mmol/l vs. 4.69 +/- 1.99 mmol/l, P < 0.0001). Glucerna subjects had a longer adjusted peak time to insulin response compared to Fresubin subjects (105.00 +/- 43.4 min vs. 88.81 +/- 37.69 min, P = 0.0050). Glucerna subjects also experienced more gradual changes in glucose and insulin values. In conclusion, Glucerna provided better control of postprandial plasma glucose and insulin levels in Chinese subjects with T-2DM. Variation of postprandial glucose tended to be relatively stable after patients took Glucerna. Study results suggest that Glucerna may be beneficial in the reduction of postprandial glycemia.