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Diabetes Review: The 2 New Insulins on the Block

Diabetes Review: The 2 New Insulins on the Block


  • Mechanism of action: long-acting human insulin analog made of an acidic formulation that forms microprecipitates in subcutaneous tissue from which insulin is slowly released.

  • Advantages: reduced injection volume, thus more gradual and prolonged insulin release, potentially lower incidence of nocturnal hypoglycemia.

  • 4 open-label, controlled, non-inferiority trials, ~800 patients each (T2DM=3, T1DM=1); compared safety/efficacy of once-daily Toujeo to once-daily Lantus combined with mealtime insulin or oral antidiabetic agents; all showed non-inferiority in reduction of A1c, FBG after 26 weeks.

  • Mechanism of action: Long-acting human insulin analog that forms multi-hexamers in subcutaneous tissue to delay absorption from depot; also highly bound to serum albumin.

  • Advantages: Lasts up to 8 weeks at room temperature; possibly less nocturnal hypoglycemia; does not have to be taken at the same time of day due to long duration of action.

  • 8 randomized, open-label, active-controlled studies (3 in T1DM, 5 in T2DM). Patients were treated with Tresiba in combination with mealtime insulin or common oral antidiabetic agents. Achieved glycemic control similar to patients treated w/ Lantus, Levemir.

  • Tresiba vs sitagliptin (patients uncontrolled on oral agents). Statistically significant improvements in A1c vs sitagliptin (A1c change: -1.52 vs. -1.09).

Two new long-acting insulin products were recently approved by the FDA. Toujeo (insulin glargine 300 units/mL) and Tresiba (insulin degludec 100 units/mL or 200 units/mL).

In clinical trials both were found comparable to Lantus (insulin glargine) and Levemir (insulin detemir [rDNA origin] injection), with regard to lowering A1c; both may also be associated with lower rates of nocturnal hypoglycemia.

Click through the 8 slides above for a quick review of more features of both.

Sources:

Toujeo [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC.; 2015.

Tresiba [package insert]. Bagsvaerd, Denmark: Novo Nordisk; 2015.

Cost information available from: REDBOOK Online.  Accessed Feb 1, 2016.

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