Skip to main content

Combination Type 2 Diabetes Pill Approved in Europe


July 27, 2012 — The European Commission has approved the combination pill containing the dipeptidyl peptidase-4 inhibitor linagliptin and metformin hydrochloride for the treatment of adults with type 2 diabetes, alongside diet and exercise. The approval follows a favorable recommendation by the European Medicines Agency in May.
The linagliptin/metformin combination sold in Europe as Jentadueto (Boehringer Ingelheim Pharmaceuticals, Inc, and Eli Lilly & Co) provides a single-tablet option that is taken twice daily.
It is intended for patients with type 2 diabetes that is inadequately controlled on their maximal tolerated dose of metformin alone, metformin plus a sulfonylurea, or those already being treated with the combination of linagliptin and metformin. It can be used alone or in combination with a sulfonylurea.
As previously reported by Medscape Medical News, the linagliptin/metformin combination was approved by the US Food and Drug Administration earlier this year.
In a 24-week, randomized, double-blind, placebo-controlled study involving 791 adults with type 2 diabetes inadequately managed with diet and exercise, 2.5 mg linagliptin/1000 mg metformin led to mean reductions in hemoglobin A1c levels of 1.7 percentage points. Statistically significant reductions in fasting plasma glucose (FPG) of −60 mg/dL were also seen.
In clinical studies, linagliptin/metformin did not cause any significant change in body weight.
Adverse reactions were uncommon in clinical studies. Gastrointestinal disorders occurred most often during the initiation period and tended to resolve spontaneously. A comparable rate of diarrhea was reported with linagliptin/metformin treatment vs metformin plus placebo.
Hypoglycemia was more commonly reported in patients treated with the combination of linagliptin/metformin and a sulfonylurea compared with those treated with the combination of placebo, metformin, and a sulfonylurea.
The linagliptin/metformin combination pill is not indicated for patients with type 1 diabetes or those who have diabetic ketoacidosis. It has not been studied in combination with insulin.
Linagliptin/metformin combination tablets will be made available in the following twice-daily doses in Europe: 2.5 mg linagliptin/850 mg metformin tablets and 2.5 mg linagliptin/1000 mg metformin tablets.

Comments

Post a Comment

Popular posts from this blog

Contact Precautions May Have Unintended Consequences

Contact precautions, including gloves, gowns, and isolated rooms, have helped stem the transmission of hospital pathogens but have also had some negative consequences, according to findings from a new study. Healthcare worker (HCWs) visited patients on contact precautions less frequently than other patients and spent less time with those patients when they did visit, report Daniel J. Morgan, MD, from the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System, Baltimore, and colleagues. Moreover, patients on contact precautions also received fewer outside visitors. "Less contact with HCWs suggests that other unintended consequences of contact precautions still exist," Dr. Morgan and coauthors write. "The resulting decrease in HCW contact may lead to increased adverse events and a lower quality of patient care due to less consistent patient monitoring and poorer adherence to standard adverse event prevention methods (such...
Post a Comment
Read more

CareFusion Issues Update on Infant Breathing Product Recall

July 5, 2012 — Medical device maker CareFusion has issued an update reminding healthcare providers of its voluntary recall of its Air Life ™ Infant Breathing Circuit, initiated back in May. The US Food and Drug Administration (FDA) has classified this action as a class 1 recall, meaning there is a reasonable probability of serious adverse health consequences or death associated with use of the defective units. The update was posted July 2 on the FDA  Website. On May 29, 2012, CareFusion sent an  Urgent Recall Notice  to customers and distributors stating that the company had identified potential risks associated with the Air Life  Infant Breathing Circuit. The action was initiated after the company received complaints of the Y adapter within the breathing circuit developing cracks during patient use. "If a crack develops in the Y adapter, this could potentially result in a leak in the closed ventilation system, leading to a loss in the intended tidal volum...
Post a Comment
Read more

Patients With IBS More Likely to Keep Taking Rifaximin

March 29, 2012 — Patients who take the antibiotic rifaximin for irritable bowel syndrome (IBS) with diarrhea are far less likely to stop using the drug because of adverse effects than patients taking 2 other common IBS treatments, according to a study by Eric Shah, MBA, from the School of Medicine at the Texas Tech University Health Sciences Center in Lubbock. The study was published online March 26 and in the April print issue of the American Journal of Medicine . A research team led by Mark Pimentel, MD, from the GI Motility Program at the Cedars-Sinai Medical Center in Los Angeles, California, reviewed 26 clinical trials of drugs for IBS with diarrhea and for IBS with constipation. In forms of IBS with diarrhea, the review found that patients experienced fewer adverse effects from the antibiotic rifaximin than patients who used tricyclic antidepressants or stool-slowing alosetron. For every 2.3 and 2.6 patients who benefited from antidepressants or alosetron, respectively, 1 had...
1 comment
Read more