The FDA has approved insulin lispro-aabc (Lyumjev – Lilly), a faster-acting formulation of insulin lispro (Humalog), for treatment of type 1 and type 2 diabetes in adults. Fiasp, a faster-acting formulation of insulin aspart (Novolog), was approved in 2017.

The goal of drug therapy for type 2 diabetes is to achieve and maintain a near-normal glycated hemoglobin (A1C) concentration without inducing hypoglycemia; for most patients, the target A1C is <7%. Metformin is the preferred first-line treatment, but most patients with type 2 diabetes eventually require multidrug therapy and/or insulin to achieve glycemic control.

View the Expanded Table: Some Available Insulins

The FDA has approved Admelog (Sanofi-Aventis), an insulin lispro product similar to Humalog (Lilly), which went off patent in 2013.

Approval of Admelog was based on efficacy data with Humalog and on two 6-month, open-label, randomized, noninferiority trials. In SORELLA 11 in 507 patients with type 1 diabetes and SORELLA 22 in 505 patients with type 2 diabetes, Admelog was noninferior to Humalog in lowering A1C, fasting plasma glucose levels, and self-monitored plasma glucose levels. The incidence of adverse effects, including hypoglycemia, was similar.

Even though Admelog is very similar to Humalog in composition, strength, and structural and biological properties, and appears to produce the same glucose-lowering effects, it was not designated as a biosimilar or an interchangeable biologic product by the FDA because of a regulatory technicality: insulin is classified as a chemical, not a biological, entity, so there is no biologic reference product for insulin lispro. Pharmacists cannot substitute Admelog for Humalog without the permission of the prescriber.  

Admelog is available in 10-mL vials and in packages of five multi-dose SoloStar pens, each prefilled with 3 mL of insulin lispro 100 units/mL. A pen can deliver 1 to 80 units per injection. It should be primed with 2 units of insulin lispro before each injection. Admelog should be injected subcutaneously within 15 minutes before a meal, or immediately after a meal.

Admelog is similar to Humalog in efficacy and safety. Patients could use either one.

1. SK Garg et al. Efficacy and safety of biosimilar SAR342434 insulin lispro in adults with type 1 diabetes also using insulin glargine – SORELLA 1 study. Diabetes Technol Ther 2017; 19:516.
2. KM Derwahl et al. Efficacy and safety of biosimilar SAR342434 insulin lispro in adults with type 2 diabetes, also using insulin glargine: SORELLA 2 study. Diabetes Technol Ther 2018; 20:49.

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The FDA has approved Fiasp (Novo Nordisk), a new formulation of insulin aspart, to improve glycemic control in adults with diabetes. Fiasp is described by the manufacturer as faster-acting than conventional insulin aspart (Novolog).

The goal of drug therapy for type 2 diabetes is to achieve and maintain a near-normal glycated hemoglobin (A1C) concentration without inducing hypoglycemia; the target is generally an A1C of ≤7%. Treating to this target has been shown to prevent microvascular complications (retinopathy, nephropathy, and neuropathy), but whether it prevents macrovascular outcomes is unclear. An A1C target of <8% may be appropriate for older patients and those with underlying cardiovascular disease, a history of severe hypoglycemia, diabetes-related complications or comorbidities, or a long duration of disease.

The FDA has approved an inhaled, rapid-acting, dry-powder formulation of recombinant human insulin (Afrezza – Mannkind/Sanofi) for treatment of adults with type 1 or type 2 diabetes. In patients with type 1 diabetes, the drug must be used in combination with long-acting insulin. Another inhaled, rapid-acting insulin (Exubera) was approved in 2006 for the same indication, but was withdrawn from the market the following year.

The goal of drug therapy for type 2 diabetes is to achieve and maintain a near-normal A1C concentration without inducing hypoglycemia; the target is generally an A1C of <7.0%. Treating to this target has been shown to prevent the microvascular complications of retinopathy and nephropathy, but whether it prevents macrovascular outcomes remains unclear. Three large trials found that intensive glucose control did not reduce the incidence of macrovascular events. One of these trials (ACCORD) in >10,000 patients with type 2 diabetes, with or at high-risk for cardiovascular disease, found that treating patients intensively with antihyperglycemic drugs to an A1C target of 6.0% for a mean of 3.7 years did not significantly reduce the incidence of major cardiovascular events (the primary endpoint) and was associated with increased all-cause mortality compared to patients treated to an A1C target of 7.0-7.9%. An A1C target of 7-8% may be prudent in older patients and in those with underlying cardiovascular disease, severe hypoglycemia, or multiple diabetes-related complications or co-morbidities.

The development of hyperglycemia in type 2 diabetes results from a combination of metabolic abnormalities that includes insulin resistance, diminished insulin secretion and excess hepatic glucose production. Diet, exercise and weight loss are helpful in improving glucose control, but most patients ultimately require drug therapy.

Three rapid-acting insulin analogs are currently available: insulin lispro, insulin aspart and insulin glulisine. 1-3 All three are approved for use in both type 1 and type 2 diabetes, either by subcutaneous injection, insulin pump or intravenous administration. All three cost more than regular insulin.

The development of hyperglycemia in type 2 diabetes results from a combination of metabolic abnormalities including insulin resistance, diminished insulin secretion and excess hepatic glucose production. Diet, exercise and weight loss are helpful in improving glucose control, but most patients ultimately require drug therapy.

Insulin glulisine (Apidra - Sanofi Aventis) is the third rapid-acting insulin analog to be marketed in the US, following insulin lispro (Humalog) and insulin aspart (Novolog). All three have a more rapid onset and shorter duration of action than regular human insulin. Rapid-acting insulin analogs are generally taken immediately before meals and are usually combined with a long-acting basal insulin.

The development of hyperglycemia in type 2 diabetes results from a combination of metabolic abnormalities including insulin resistance, excess hepatic glucose production and diminished insulin secretion. In many patients, diet and regular exercise can improve glucose control. Most drugs currently available for management of type 2 diabetes increase insulin supply (sulfonylureas, other secretagogues and insulin itself), decrease insulin resistance (thiazolidinediones) or improve the effectiveness of insulin (biguanides). Alpha-glucosidase inhibitors reduce the rate of glucose absorption. Newer agents such as pramlintide (Symlin) and exenatide (Byetta) have multiple effects to increase satiety and reduce postprandial hyperglycemia.

The development of hyperglycemia in type 2 diabetes results from a combination of metabolic abnormalities including insulin resistance, excess hepatic glucose production and diminished insulin secretion. Most drugs currently available for management of type 2 diabetes fall into 2 categories: those that increase insulin supply (sulfonylureas, other secretagogues and insulin itself) and those that decrease insulin resistance or improve its effectiveness (biguanides, thiazolidinediones). Alpha-glucosidase inhibitors reduce the rate of glucose absorption.

Insulin aspart (Novolog - Novo Nordisk) is the second rapid-acting insulin analog to be approved by the FDA. The first was insulin lispro (Humalog). Insulin aspart differs from human insulin by substitution of aspartic acid for proline in position 28 on the beta-chain.

Lispro insulin (Humalog - Lilly), a synthetic insulin analog, has been approved for marketing by the US Food and Drug Administration. Prepared by recombinant DNA methods using E. coli, lispro differs from human insulin in having lysine and proline at positions 28 and 29 on the beta-chain, reversed from their natural position. The new drug has biologic effects similar to unmodified insulin, but is absorbed more rapidly after subcutaneous injection.