Tag: diabetes

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2020 Saw Huge Growth in Metformin Recalls

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The year 2020 saw huge numbers of metformin products being removed from shelves due to contamination concerns. Metformin is an antidiabetic agents used to treat type 2 diabetes mellitus, and comes as immediate-release and extended-release products.

In May 2020, the US Food and Drug Administration (FDA) announced that it had recommended certain extended-release metformin products to be removed from shelves, as they were contaminated with N-nitrosodimethylamine (NDMA), a potential carcinogen. This followed a December 2019 announcement that the FDA was aware of there being low levels of NDMA in metformin products outside of the US. Lab studies showed NDMA in US products in February, although the FDA only recommended voluntary recalls of metformin products on May 28. Participating in the recall of extended-release metformin were five companies, of which one, Apotex and Amneal, recalled all of its lots.

Whilst NDMA is ubiquitous in daily life, found in cured and grilled foods as well as contaminated water, the daily limit was set at 96ng, specifically because such a dose would lead to a 1 in 100 000 increase in cancer risk after 70 years of exposure.

Prompted by a report from a private laboratory stating that 16 of 38 metformin products tested exceeded the daily NDMA limit, the FDA released its own article in the journal American Association of Pharmaceutical Scientists, stating the reasoning behind its recommendation for voluntary recall. The FDA noted that its own testing only found eight products of the 38 exceeded the NDMA limit, and explained that N,N-dimethylformamide (DMF) conflated levels in mass spectrometry measurements.

However, this was followed in July by an additional set of recalls, and yet more in August and October. Separately, Sun Pharmaceuticals issued a recall for its relatively new extended-release oral suspension (brand name Riomet ER; 500 mg/5 mL) which had only received approval in February.However, none of the FDA’s recalls have extended to immediate-release metformin, which is the most commonly prescribed form of the drug.

Source: MedPage Today

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Exenatide and Dapagliflozin Outlast Metformin for Diabetes Treatment

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An AstraZeneca-funded trial called DURATION-8 has shown a viable alternative for metformin with a combination of two medications, exenatide and dapagliflozin.

The standard treatment for type 2 diabetes is metformin, but for many patients it loses its effectiveness over time. To get around this, a combination of exenatide (a glucagon-like peptide-1 receptor agonist) and dapagliflozin (sodium-glucose cotransporter-2 inhibitor) was trialled.

Originally a 28 week trial, DURATION-8 was extended to 52 weeks on the strength of its initial results.

“Many therapies in diabetes management are short-lived, which is why it is useful to test for long-term effect,” says first author Dr Serge Jabbour, director of the division of endocrinology and the Diabetes Center at Thomas Jefferson University.

The trial, with 695 participants, compared the two medications, either individually with a placebo or in combination. The combination group saw the greatest drop in glycated hemoglobin (HbA1c) levels. This was accompanied by drops in systolic blood pressure and body weight.

The authors note the need for a follow-on study to determine if there were protective effects against cardiovascular and renal events with the combination.

Source: Medical News Today

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Electromagnetic fields treat diabetes in animal models

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According to Medial Express, electromagnetic fields (EMF) may be a new way to modulate blood glucose levels. Scientists found that when drawing blood from mice borrowed from an experiment which had them to low level EMF, the typical high blood sugar in these animals was found to be lowered. 

Carter and Huang are energized by the possibility of translating the findings to human patients with type 2 diabetes. In terms of safety, the World Health Organization considers low energy EMFs safe for human health. The UI study also found no evidence of any adverse side effects in mice.

The team is now working on a larger animal model to see if the EMFs produce similar effects in an animal that has a more similar size and physiology to humans. They also plan to conduct studies to understand the redox mechanism underlying the effects of EMFs. Their ultimate goal is to move into clinical trials with patients to translate the technology into a new class of therapies. With that goal in mind, Carter, Huang, and Carter’s twin brother, Walter, have created a startup company called Geminii Health, with help from the UI Office for the Vice President of Research.

“Our dream is to create a new class of non-invasive medicines that remotely take control of cells to fight disease,” Carter says.

The multidisciplinary research team also included scientists from the UI Departments of Radiology, Neuroscience and Pharmacology, Molecular Physiology and Biophysics, and Physics and Astronomy, as well as colleagues from Vanderbilt University.