Metformin (Glucophage - Bristol-Myers Squibb), a hypoglycemic agent, was recently marketed in the USA for oral treatment of patients with non-insulin-dependent diabetes mellitus (NIDDM) not adequately controlled by diet alone. Previously marketed in more than ninety countries, including Canada, metformin (dimethylbiguanide) is chemically related to phenformin (phenylethylbiguanide), which was withdrawn from the US market in 1976 because it caused a high incidence of lactic acidosis. In approving metformin, the US Food and Drug Administration stipulated that a post-marketing controlled...

The FDA has approved the Minimed 670G (Medtronic), a hybrid closed-loop insulin delivery system for use in patients ≥14 years old with type 1 diabetes. The system uses an algorithm to automatically adjust basal insulin doses based on readings from a continuous glucose monitor (CGM). It fully automates basal insulin delivery in "auto" mode, but is considered a "hybrid" system (not a true "artificial pancreas") because it requires some action by the patient. The 670G system is expected to become available in Spring 2017.

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...

Insulin glargine-aglr (Rezvoglar – Lilly), which was approved by the FDA as a biosimilar to the reference product Lantus in 2021 and received interchangeability status with Lantus in 2022, will become available in the US on April 1, 2023. It is the second biosimilar insulin product to be designated as interchangeable with Lantus; Semglee was the first. Rezvoglar did not receive interchangeability status with Lantus at the time of its initial approval because the manufacturer of Semglee had exclusivity for 12 months.

Drugs for Diabetes (Med Lett Drugs Ther 2017; 59:9)In the 4th paragraph of the GLP-1 receptor agonists section, we mistakenly stated that Xultophy 100/3.6 is a combination of insulin degludec and albiglutide; Xultophy 100/3.6 is a combination of insulin degludec and liraglutide.Another Insulin Glargine (Basaglar) for Diabetes (Med Lett Drugs Ther 2017; 59:3)In the Dosage and Administration section, we removed the word "syringe" to describe Basaglar's KwikPen device. Basaglar is not available as a prefilled syringe; it is only available as a KwikPen.Download complete U.S. English...

Mecasermin (Increlex - Tercica), which is injected subcutaneously, has been approved by the FDA for treatment of growth failure in children with severe primary insulin-like growth factor (IGF-1) deficiency. Mecasermin is recombinant human (rh) IGF-1. It has also been approved to treat children with short stature who are deficient in growth hormone (GH), but have developed neutralizing antibodies in response to GH treatment. A similar product, mecasermin rinfabate (Iplex - Insmed), that was approved by the FDA for the same indications was withdrawn from the market due to patent...

The FDA has approved the MiniMed 530G (Medtronic), an insulin pump used in combination with a continuous glucose monitoring sensor (Enlite) that can stop delivery of insulin when interstitial glucose reaches a prespecified low level. It is the only sensoraugmented insulin pump available in the US with this capability.

View the Expanded Table: Some Available Insulins

The FDA has approved Xultophy 100/3.6 (Novo Nordisk), a fixed-ratio combination of insulin degludec and the GLP-1 (glucagon-like peptide-1) receptor agonist liraglutide, for once-daily treatment of adults with type 2 diabetes inadequately controlled on basal insulin (<50 units daily) or liraglutide (≤1.8 mg daily).

The FDA has approved lixisenatide (Sanofi), a short-acting injectable GLP-1 (glucagon-like peptide-1) receptor agonist, for once-daily treatment of adults with type 2 diabetes, both alone (Adlyxin) and in a fixed-ratio combination with insulin glargine (Soliqua 100/33). Lixisenatide has been available since 2013 in many other countries as Lyxumia. It is the fifth GLP-1 receptor agonist to be approved in the US.