Comparison of acarbose and metformin as add-on therapy to insulin in uncontrolled patients with type 2 diabetes mellitus: A randomized, open-labeled, and parallel group study / 中华内分泌代谢杂志

ABSTRACT

Objective To evaluate efficacy and safety of acarbose compared with metformin as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled with insulin. Methods This was a randomized, open-labeled, and parallel group study. Ninety-one type 2 diabetic patients ( HbA1C7.5%-11.0%) who were suboptimally controlled despite receiving twice daily injection of insulin (30-60 U/d for at least 8 weeks) were enrolled. They were randomly assigned 1 ∶ 1 ∶ 1 to continuation of insulin, insulin with acarbose (Ins+Aca), and insulin with metformin (Ins+Met) groups to insulin treatment. The levels of HbA1C, oral glucose tolerance test, blood lipids etc were measured at baseline and 12 weeks, and adverse events were recorded. Results The mean HbA1C levelsdecreasedfrom(7.9±0.4)%atbaselineto(7.0±0.3)%atweek12(P＜0.01)intheIns+Acagroupand(7.8 ±0.2)%to(7.0±0.3)%in the Ins+Met group(P＜0.01), while no significant change in HbA1Cin the insulin alone group. Adding acarbose to insulin resulted in similar reductions in HbA1Crelative to metformin (P＝0.431). The achievement rate of HbA1Cbelow 7.0%at week 12 was the same(both 70%) between the Ins+Aca group and the Ins+Met group. Insulin combined with acarbose in improving blood glucose fluctuation effect was more significant than that incombinationwithmetformin(P＜0.01),withstandarddeviation(SD)ofbloodglucose[(1.1±0.5vs2.7±0.6) mmol/L, P＜0.01], postprandial blood glucose fluctuations [(0.5 ± 0.7 vs 2.8 ± 0.4) mmol/L, P＜0.01], the maximumbloodglucosefluctuations[(2.8±0.7vs4.6±0.6)mmol/L,P＜0.01].Theweightlossoccurredinboththe Ins+AcaandtheIns+Metgroups[-(0.5±0.8vs1.0±0.4)kg].Therewasnosignificantchangesinbloodpressure and lipid profile. Hypoglycemic episodes were comparable in all groups. No serious adverse event was noted in any group. Conclusions Adding acarbose or metformin to insulin therapy could achieve improvements in glycemic control with similar reductions in HbA1Clevels and weight, when comparing with insulin treatment alone. Add-on acarbose to insulin therapy may exist more effectively on glucose fluctuation than that of add-on metformin, which may have important clinical implications in those patients with postprandial hyperglycemia, large blood glucose fluctuation, and intolerance to metformin.