Jentadueto Approved by FDA for Type 2 Diabetes Mellitus

By: Ebey P. Soman

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The FDA recently approved a combination tablet of linagliptin with metformin hydrochloride (Jentadueto®) for the treatment of type 2 diabetes.  Developed by Boehringer Ingelheim and Eli Lilly, the new combination tablet provides a twice-daily treatment option for healthcare providers looking for greater flexibility in treating diabetes.

Prescribers may add a sulfonylurea to linagliptin/metformin for greater glycemic control.  Placebo-controlled trials demonstrated that the drug lowers hemoglobin A1C levels by 1.7%.  The most common side effects (>5%) were nasopharyngitis and diarrhea.  Linagliptin/metformin did not cause any weight gain, unlike other treatment options (such as thiazolidinediones and certain insulins).  Hypoglycemia is still a risk factor for patients treated with linagliptin/metformin and sulfonylurea.  As with other “gliptins,” pancreatitis is still a possible adverse effect.  The drug also carries a Black Box Warning for the risk of lactic acidosis, particularly because of the metformin component.

There are no studies regarding the safety profile of the drug when used in conjunction with insulin.  Clinical trials demonstrating the efficacy of linagliptin/metformin examined separate administrations of linagliptin and metformin.  Researchers determined bioequivalence by co-administrating separate linagliptin and metformin tablets.  It would be interesting to see more safety and efficacy trials for this drug based upon the combination tablet, and not the co-administration of linagliptin and metformin.

Jentadueto® will be available in pharmacies by this summer.

SOURCES:

1. Jentadueto [linagliptin and metformin hydrochloride] package insert.
2. Formulary staff. FDA approves tablets for adult patients with type 2 diabetes. Website. Available online: http://formularyjournal.modernmedicine.com/formulary/FDA+Approvals/FDA-approves-tablets-for-adult-patients-with-type-/ArticleStandard/Article/detail/757904?contextCategoryId=44276. 2012 Feb. Last accessed Feb 29, 2012.