Glycaemic Control of Type 2 Diabetics with Insulin Glargine in Everyday Practice Type 2 diabetic patients poorly controlled on insulin detemir therapy benefit from switching to insulin glargine
Abstrakt
Background: In the RESOLUTE study, we investigated whether patients, with type 2 diabetes (T2D) inadequately controlled with insulin detemir (DET) in combination with oral anti-diabetic drugs (OADs) would benefit from switching to insulin glargine (GLA) (plus OADs) in everyday clinical practice. Methods: We performed this prospective, multinational, non-interventional, six-month observational study between June 2010 and November 2011.
T2D patients with HbA(1c) > 7 to 10% (<53 to 86 mmol/mol) treated for at least three months with DET combined with OADs were documented after switching to GLA at the physician's discretion. The primary endpoint was the change in HbA(1c) after six months.
Results: Of 564 T2D patients included in the study, 511 (61% female) were eligible for analysis (mean age: 61.9 +/- 10.1 years, BMI 30.9 +/- 5.1 kg/m(2), duration of diabetes 9.2 +/- 5.9 years). HbA(1c) decreased from 8.4 +/- 0.8% (61 10 mmol/mol) at baseline to 7.3 +/- 1.0% (56 +/- 11 mmol/mol) (p < 0.001, Wilcoxon test) at six months and FBG from 8.9 +/- 2.1 to 6.8 +/- 1.7 mmol/l (p < 0.001), with 40% of patients achieving HbA(1c) < 7% (53 mmol/mol).
Body weight change was -0.2 +/- 2.5 kg with GLA. The incidence of symptomatic, nocturnal and severe hypoglycaemia was less in the last month on GLA than in the last month on DET-therapy, and 2.4% of GLA patients reported adverse events.
Conclusions: Under real-life conditions, switching from DET to GLA once daily in poorly controlled T2D patients resulted in clinically relevant improvements in glycaemic control without any increase in weight or hypoglycaemia risk.