K Strojek1, C Shi, M A Carey, S J Jacober. 1. Department of Internal Diseases, Diabetology and Nephrology, Silesian Medical University, Zabrze, Poland.
Abstract
AIMS: The addition of basal insulin to existing oral therapy can help patients with type 2 diabetes (T2D) achieve glycaemic targets. This study compares the efficacy and safety of insulin lispro protamine suspension (ILPS) and insulin glargine in insulin-naive patients with T2D and inadequate control on oral antihyperglycaemic medication (OAM). MATERIALS AND METHODS: An open-label, randomized, multicentre, multinational 24-week study of 471 patients receiving ≥2 OAMs for ≥3 months with a body mass index between 25 and 45 kg/m(2) and HbA1c 7.5-10.0% was conducted. ILPS was injected once or twice daily vs. glargine injected once daily plus prestudy OAMs. Primary objective compared the HbA1c change from baseline. RESULTS:HbA1c change from baseline to endpoint was similar in both groups [-1.46% (ILPS) and -1.41% (glargine)]. Least-squares mean difference (95% CI) for HbA1c (-0.05 [-0.21, 0.11]%), glycaemic variability (0.06 [-0.06, 0.19] mmol/l) and weight change (-0.01 [-0.61, 0.59] kg) showed non-inferiority (margins of 0.4%, 0.8 mmol/l and 1.5 kg, respectively). Percentages of patients achieving HbA1c <7.0% were 43.8% ILPS and 41.2% glargine. Mean daily insulin dose was 0.39 vs. 0.35 U/kg (p = 0.02) and weight gain was 1.04 vs. 1.07 kg for ILPS vs. glargine (p = 0.98). Overall hypoglycaemia (episodes/patient/year) was similar for ILPS and glargine (24.2 ± 28.8 vs. 23.0 ± 30.9); nocturnal (6.1 ± 10.6 vs. 4.1 ± 9.4, p < 0.001) rates were higher for ILPS. Severe hypoglycaemia was higher for ILPS vs. glargine (n = 9 vs. n = 2; p = 0.04). CONCLUSIONS: At endpoint, ILPS was non-inferior to glargine in HbA1c change from baseline, but associated with increased risk of hypoglycaemia.
RCT Entities:
AIMS: The addition of basal insulin to existing oral therapy can help patients with type 2 diabetes (T2D) achieve glycaemic targets. This study compares the efficacy and safety of insulin lispro protamine suspension (ILPS) and insulin glargine in insulin-naivepatients with T2D and inadequate control on oral antihyperglycaemic medication (OAM). MATERIALS AND METHODS: An open-label, randomized, multicentre, multinational 24-week study of 471 patients receiving ≥2 OAMs for ≥3 months with a body mass index between 25 and 45 kg/m(2) and HbA1c 7.5-10.0% was conducted. ILPS was injected once or twice daily vs. glargine injected once daily plus prestudy OAMs. Primary objective compared the HbA1c change from baseline. RESULTS: HbA1c change from baseline to endpoint was similar in both groups [-1.46% (ILPS) and -1.41% (glargine)]. Least-squares mean difference (95% CI) for HbA1c (-0.05 [-0.21, 0.11]%), glycaemic variability (0.06 [-0.06, 0.19] mmol/l) and weight change (-0.01 [-0.61, 0.59] kg) showed non-inferiority (margins of 0.4%, 0.8 mmol/l and 1.5 kg, respectively). Percentages of patients achieving HbA1c <7.0% were 43.8% ILPS and 41.2% glargine. Mean daily insulin dose was 0.39 vs. 0.35 U/kg (p = 0.02) and weight gain was 1.04 vs. 1.07 kg for ILPS vs. glargine (p = 0.98). Overall hypoglycaemia (episodes/patient/year) was similar for ILPS and glargine (24.2 ± 28.8 vs. 23.0 ± 30.9); nocturnal (6.1 ± 10.6 vs. 4.1 ± 9.4, p < 0.001) rates were higher for ILPS. Severe hypoglycaemia was higher for ILPS vs. glargine (n = 9 vs. n = 2; p = 0.04). CONCLUSIONS: At endpoint, ILPS was non-inferior to glargine in HbA1c change from baseline, but associated with increased risk of hypoglycaemia.
Authors: Przemyslaw Rys; Piotr Wojciechowski; Agnieszka Rogoz-Sitek; Grzegorz Niesyczyński; Joanna Lis; Albert Syta; Maciej T Malecki Journal: Acta Diabetol Date: 2015-01-14 Impact factor: 4.280
Authors: R F Arakaki; T C Blevins; J K Wise; D R Liljenquist; H H Jiang; J G Jacobson; S A Martin; J A Jackson Journal: Diabetes Obes Metab Date: 2013-12-29 Impact factor: 6.577