Safety and Efficacy of Modern Insulin Analogues

Abstract

BackgroundA1chieve® was a noninterventional study evaluating the clinical safety and efficacy of biphasic insulin aspart 30, insulin detemir, and insulin aspart.MethodsKorean type 2 diabetes patients who have not been treated with the study insulin or have started it within 4 weeks before enrollment were eligible for the study. The patient selection and the choice of regimen were at the discretion of the physician. The safety and efficacy information was collected from the subjects at baseline, week 12, and week 24. The number of serious adverse drug reactions (SADRs) was the primary endpoint. The changes of clinical diabetic markers at week 12 and/or at week 24 compared to baseline were the secondary endpoints.ResultsOut of 4,058 exposed patients, 3,003 completed the study. During the study period, three SADRs were reported in three patients (0.1%). No major hypoglycemic episodes were observed and the rate of minor hypoglycemic episodes marginally decreased during 24 weeks (from 2.77 to 2.42 events per patient-year). The overall quality of life score improved (from 66.7±15.9 to 72.5±13.5) while the mean body weight was slightly increased (0.6±3.0 kg). The 24-week reductions in glycated hemoglobin, fasting plasma glucose and postprandial plasma glucose were 1.6%±2.2%, 2.5±4.7 mmol/L, and 4.0±6.4 mmol/L, respectively.ConclusionThe studied regimens showed improvements in glycemic control with low incidence of SADRs, including no incidence of major hypoglycemic episodes in Korean patients with type 2 diabetes.

The glycemic efficacies of insulin analogue regimens according to baseline glycemic status in Korean patients with type 2 diabetes: sub‐analysis from the A 1 chieve ® study

“…In a previous A 1 chieve® study report in Korea (2), HbA 1c decreased from 9.7% at baseline to 8.1% at the 24-week end-point, resulting in a significant reduction of 1.6 ± 2.2% (p < 0.001). In addition, the proportion of patients who achieved the target HbA 1c level of < 7.0% increased from 4.8% at baseline to 18.1% at the 12-week interim and 22.7% at the 24-week end-point.…”

“…Although randomised clinical trials are considered the gold standard, the non-interventional study design evaluates effectiveness and optimal regimens in real clinical practice (4,10). Based on a previous report (2), treatment with insulin analogues (aspart, biphasic aspart 30, detemir, or detemir and aspart) reduced HbA 1c , FPG and PPG levels during the 24-week of treatment period (1.6 ± 2.2%, 2.5 ± 4.7 and 4.0 ± 6.4 mmol/l, respectively).…”

“…The study population and design were described in a previous report (2). Briefly, Korean patients with T2D, including those who were started on biphasic aspart 30, detemir or aspart within the 4 weeks prior to the initiation of the study were eligible to participate in the study.…”

“…In the A 1 chieve® study conducted in Korea, the treatment with insulin analogues showed beneficial 24-week reductions in HbA 1c , fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) (−1.6 ± 2.2%, −2.5 ± 4.7 and −4.0 ± 6.4 mmol/l, respectively). In addition, the overall quality of life score was improved, while no major hypoglycaemic episodes were observed and the rate of minor hypoglycaemic episodes marginally decreased (2). …”

Characteristics Predictive for a Successful Switch from Insulin Analogue Therapy to Oral Hypoglycemic Agents in Patients with Type 2 Diabetes

“…As proof-of-concept, earlier and more intensive insulin initiation in patients with newly diagnosed T2D resulted in not only a great improvement in glycemic control, but also a modified natural history of diabetes through restoration and preservation of pancreatic β-cell function 45. In this regard, some controversy might remain over whether appropriate implementation of insulin analogues, even in subjects with a moderate duration of T2D, is expected to achieve the targeted HbA1c while minimising side effects such as hypoglycaemia 67. To address this, many questions should be clarified in real clinical practice, such as when to initiate insulin (before or after islet failure), which patients to initiate treatment in, which kind of insulin analogue (basal, rapid-acting, biphasic, or combination of basal and rapid-acting insulin analogue) should be used, and how to administer insulin (starting dose, number of injections, divided ratio of total doses, and titration methods) 8910.…”