First once-weekly basal insulin is now approved in Canada

Health Canada has authorized Novo Nordisk’s Awiqli (insulin icodec 700 units/mL solution for subcutaneous [SC] injection), the first once-weekly basal insulin to be approved in Canada. The new long-acting insulin is indicated for the once-weekly treatment of adults with diabetes to improve glycemic control.1 In patients with type 1 diabetes, insulin icodec must be used in regimens containing a rapid-acting or short-acting insulin to cover mealtime insulin requirements (i.e., as part of a basal-bolus insulin regimen). In patients with type 2 diabetes, it can be used in combination with oral antidiabetic agents when treatment with oral antidiabetic agents does not achieve adequate glycemic control.1Action Insulin icodec binds reversibly to albumin, resulting in a depot in the circulation from which insulin icodec is slowly released. Steady-state dosing results in an evenly distributed glucose-lowering effect across the one-week dosing interval. The half-life after SC administration is about one week, independent of dose.1Dosage Basal insulin-naïve patients: There is no clinical trial experience with insulin icodec in patients with type 1 diabetes who were not previously on a basal-bolus insulin regimen. In insulin-naïve patients with type 2 diabetes, the recommended starting dose is 70 units administered SC once weekly.1 Patients switching from another basal insulin therapy: When switching from a previous daily basal insulin to once-weekly insulin icodec, close glucose monitoring is recommended. The doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant antidiabetic treatment may need to be adjusted. The first weekly dose of insulin icodec should be administered on the day following the last dose of once- or twice-daily basal insulin. When switching patients from once- or twice-daily basal insulin, the corresponding weekly insulin icodec dose is the previous daily basal insulin dose multiplied by 7, rounded to the nearest 10 units. Subsequent doses of insulin icodec can be titrated based on the patient’s metabolic needs, blood glucose monitoring results and glycemic control goal. Consult the product monograph for details about patients who may require a one-time additional dose in Week 1.1Administration Inject insulin icodec SC once weekly into the thigh, upper arm or abdomen. Rotate injection sites to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Insulin icodec can be given on any day of the week at any time of day, but preferably on the same day each week.1 Adverse effects Hypoglycemia is the most common adverse effect. Injection site reactions, weight gain and peripheral edema may also occur.1 The maximum glucose lowering effect of insulin icodec occurs during Days 2–4 of the weekly dosing cycle, with an increased risk of hypoglycemia on these days. When starting insulin icodec, patients should pay special attention to blood glucose and symptoms of hypoglycemia during this period. Insulin icodec should not be used in patients with a history of hypoglycemia unawareness.1 In clinical studies, severe or clinically significant hypoglycemic episodes occurred at rates of 8.9%–11.8% with insulin icodec compared to 6.1%–10.6% with daily basal insulin in insulin-naïve patients with type 2 diabetes; 14% vs 7% in patients with type 2 diabetes treated with basal insulin; 51% vs 56% in patients with type 2 diabetes previously on a basal-bolus insulin regimen; and 85% vs 76% in patients with type 1 diabetes.1 Severe, life-threatening generalized allergy (including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension and shock), may occur with any insulin, including insulin icodec.1 Storage/stability Unopened pens can be stored under refrigeration (2°C–8°C) until the expiry date, or at room temperature (< 30°C) for 12 weeks. Once opened, pens can be kept at room temperature (< 30°C) or under refrigeration (2°C–8°C) for 12 weeks.1Supplied Awiqli will be available in 1.5 and 3 mL single-patient-use FlexTouch pens. The prefilled FlexTouch pen delivers doses in 10-unit increments and can deliver up to 700 units in a single injection.1 Novo Nordisk is working to market Awiqli as soon as possible, but no launch date has yet been announced.Comparative efficacy and safety A recent meta-analysis of five clinical trials with 3,764 participants with type 2 diabetes showed that once-weekly insulin icodec resulted in a higher glycated hemoglobin (A1C) reduction compared with other basal insulin analogues (mean difference −0.17%, 95% confidence interval [CI]; −0.28 to −0.06), p=0.003), with no significant difference in fasting plasma glucose. With insulin icodec, higher proportions of patients achieved an A1C < 7% (odds ratio 1.51, 95% CI (1.14–1.99), p=0.004) and an A1C < 7% without hypoglycemia (odds ratio 1.45, 95% CI (1.26–1.67), p

First once-weekly basal insulin is now approved in Canada

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