Insulin glargine compared with premixed insulin for management of insulin-naïve type 2 diabetes patients uncontrolled on oral antidiabetic drugs: the open-label, randomized GALAPAGOS study

Abstract

Glargine (±glulisine) and premix strategies resulted in similar percentages of well-controlled patients without hypoglycemia, with more patients achieving target HbA1c with premix whereas overall symptomatic hypoglycemia was less with glargine.

Clinical Outcomes After Switching From Premixed Insulin to Basal Insulin in Patients With Type 2 Diabetes Mellitus in Everyday Care in the Gulf Region: The I-Talent Study.

“…The lack of a comparator makes it difficult to assess the specific effect of insulin glargine. However, the improvements in glycemic control over the study period are consistent with previous randomised controlled trials performed in patients not optimally controlled with premixed insulin and who switched to insulin glargine (Inzucchi, 2015, Aschner et al, 2015. Secondly, the decision to initiate insulin glargine was not based on a planned treatment algorithm but was made at the discretion of the physician at the consultation visit.…”

Similar glucose control with basal–bolus regimen of insulin detemir plus insulin aspart and thrice-daily biphasic insulin aspart 30 in insulin-naive patients with type 2 diabetes: Results of a 50-week randomized clinical trial of stepwise insulin intensification

“…Aschner et al [15] compared glycaemic control in insulin-naive T2DM patients taking insulin glargine (QD with/without glulisine) versus premixed insulin (QD/BID). The primary endpoint-the percent of patients achieving an HbA 1c <7% with no symptomatic hypoglycaemia-was similarly achieved at the end of 24 weeks, demonstrating the non-inferiority of insulin glargine and rapidacting insulin versus premixed insulin.…”

Premixed insulin regimens for type 2 diabetes

“…Likewise, a more recent meta-analysis demonstrated that treatment with biphasic insulin aspart 30 (aspart/aspart protamine 30/70) once or twice daily resulted in better glycemic control in comparison with insulin glargine once daily (-0.21 %; -0.35 to -0.08) [9]. Similarly, the recently published GALAPA-GOS study demonstrated that in insulin-naive patients, premixed insulin once or twice daily reduced HbA 1c by a further 0.16 % (confidence interval 0.04 to 0.27) compared with insulin glargine with or without insulin glulisine [10]. Finally, in a subgroup analysis in insulin-naïve patients, premixed regimen had no difference with basal-bolus regimens (-0.15 %; -0.52 to 0.22) [11].…”

“…This was corroborated in a pooled analysis of three studies comparing biphasic insulin aspart 30 twice daily with insulin glargine once daily in insulin-naïve patients (1.16 kg; -0.41 to 2.74) [9]. Similarly, body weight increase in insulin-naive patients in the GALA-PAGOS trial was comparable between those randomized to insulin glargine with or without insulin glulisine once daily and those treated with a premixed insulin regimen once or twice daily (LS mean difference -0.3 kg; p = 0.12) [10]. Likewise, in the LanScape trial, there was no difference in weight gain between basal-plus and biphasic insulin regimens (-0.44 kg; -1.12 to 0.23) in patients inadequately controlled on basal insulin and oral antidiabetic agents [12].…”

“…In the same meta-analysis, there was no difference in the incidence of severe hypoglycemia between biphasic aspart and glargine regimens (odds ratio 0.88; 0.31-2.53) [9]. However, data from the GALAPAGOS study which was not included in the aforementioned meta-analysis suggest that, in insulin-naïve patients, biphasic insulin aspart 30 is associated with an increased risk both for overall or nocturnal symptomatic hypoglycemia compared with basal insulin or a basal-plus regimen (22 vs. 35.2 % and 7.3 vs. 18.7 %, respectively) [10]. On the contrary, results from an RCT in patients already treated with basal insulin showed no difference in the incidence rate of any hypoglycemia between basal-plus and premixed insulin regimens (estimated rate ratio 0.84; 0.64-1.11) [12].…”