Safety and efficacy of insulin detemir in clinical practice: 14-week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVETM European cohort

Abstract

PREDICTIVE (Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation) is a large, multi-national, open-label, prospective, observational study assessing the safety and efficacy of insulin detemir in clinical practice. A total of 20,531 patients with type 1 or 2 diabetes from 11 countries were prescribed insulin detemir and followed up after a mean of 14.4 weeks. The primary endpoint was incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia. Secondary endpoints were: haemoglobin A(1c) (HbA(1c)), mean self-monitored fasting glucose, within-patient fasting glucose variability and body weight change. Two hundred and fourteen patients (1%) reported SADRs, including major hypoglycaemia. The incidence of major hypoglycaemic episodes was reduced from 3.0/patient-year at baseline to 0.7/patient-year at follow-up in type 1 patients (p < 0.0001), and from 0.8 to 0.1/patient-year in type 2 patients (p < 0.0001). Insulin detemir improved glycaemic control in type 1 and type 2 patients, with reductions in mean HbA(1c) (0.5% and 0.9%, respectively, p < 0.0001 for both), fasting glucose (1.7 and 2.6 mmol/l, p < 0.0001 for both) and within-patient fasting glucose variability (0.7 and 0.5 mmol/l, p < 0.0001 for both). There was a small decrease in mean body weight in both type 1 and 2 patients (-0.1 kg, p < 0.01 and -0.4 kg, p < 0.0001 respectively). Insulin detemir was used once- or twice-daily in 49% and 50% of type 1 patients, and 77% and 23% of type 2 diabetes patients, respectively. The 14-week observations from PREDICTIVE support clinical trial data showing that insulin detemir improves glycaemic control, with a lowered risk of hypoglycaemia and no weight gain.

Iowa medicaid 2: lapse of glycemic control on abrupt transition from insulin glargine to insulin detemir in type 2 diabetes mellitus

“…This finding is consistent with observations in another study in which a substantial reduction in daily dose of insulin glargine was noted with a transition from insulin detemir in subjects with type 2 Diabetes [9]. Several other studies have also documented a requirement of a higher daily dose of insulin detemir in comparison to insulin glargine to attain comparable glycemic control [10][11][12][13][14][15][16][17][18][19]. Thus, a higher daily dose and twice daily administration of insulin detemir may have been required to achieve desirable glycemic goal in this study as documented in previous studies in most subjects with both Type 1 and Type 2 diabetes [1,[10][11][12][13][14][15][16][17][18][19].…”

“…Several other studies have also documented a requirement of a higher daily dose of insulin detemir in comparison to insulin glargine to attain comparable glycemic control [10][11][12][13][14][15][16][17][18][19]. Thus, a higher daily dose and twice daily administration of insulin detemir may have been required to achieve desirable glycemic goal in this study as documented in previous studies in most subjects with both Type 1 and Type 2 diabetes [1,[10][11][12][13][14][15][16][17][18][19]. The requirement for a higher daily dose for insulin detemir in comparison to insulin glargine in order to achieve identical glycemic control in type 2 Diabetes is further confirmed in a recent study examining pharmacokinetics and pharmacodynamics of these insulins [20].…”

Comparison of Pharmacokinetics and Dynamics of the Long-Acting Insulin Analogs Glargine and Detemir at Steady State in Type 1 Diabetes

“…A clinical trial has shown noninferiority with detemir given once daily compared with twice daily in type 1 diabetes in terms of percentage of A1C (29). In an observational trial, 49% of subjects with type 1 diabetes were treated with detemir once daily (30). On the other hand, several trials designed to optimize replacement of basal insulin needs with detemir have used detemir twice daily in type 1 diabetes (26,31).…”

Efficacy and safety of insulin degludec in Japanese patients with type 1 and type 2 diabetes: 24‐week results from the observational study in routine clinical practice

“…Regarding long‐acting insulin analogs (e.g., insulin detemir and insulin glargine), these treatments are associated with a lower incidence of nocturnal hypoglycemia than existing intermediate type insulin preparations4, 5, 6, 7. However, there are cases where neither of these treatments, when administered using the daily basal insulin regimen, provides sufficient activity for 24 h, thus necessitating a twice‐daily regimen8, 9.…”