(This is an excerpt of the Health Rounds newsletter, where we present latest medical studies on Tuesdays and Thursdays.)
By Nancy Lapid
(Reuters) -Children with diabetes who inhaled their mealtime doses of insulin did just as well as those who injected insulin under the skin, researchers reported at the American Diabetes Association scientific meeting in Chicago.
To regulate their blood sugar, patients with type 1 diabetes usually require an injection of a long-acting basal insulin once a day, plus additional injections of rapid-acting insulins at mealtimes.
MannKind’s inhaled insulin Afrezza is approved for use by adults but not yet for children, which prompted the study.
The 230 children with type 1 diabetes, ages 4 to 17, who participated in the trial received either Afrezza at mealtimes, or their usual mealtime injections of insulin, for 26 weeks. Everyone continued to receive their basal insulin injections.
Control of hemoglobin A1c, a marker of blood sugar control over the past several months, was comparable with the inhaled insulin and the injected insulin, the researchers found.
Inhaled insulin was also associated with less weight gain and slightly higher child and parent preference scores.
The inhaled formula did not have any adverse effects on patients’ lungs, the researchers reported.
“Inhaled insulin is the fastest acting insulin available and is a valuable alternative to injected analogue insulin,” study leader Dr. Michael Haller of the University of Florida said in a statement. “Afrezza should be available as an option to all children and adults with type 1 diabetes.”
ONCE-WEEKLY INSULIN PROMISING FOR TYPE 2 DIABETES
Eli Lilly’s experimental once-weekly insulin efsitora was comparable to daily insulins in nearly a thousand adults with type 2 diabetes in three late-stage trials, researchers reported at the ADA meeting.
The trials, which were designed to study patients at different stages of insulin use, each found efsitora to be just as effective as daily insulins for bringing HbA1c levels – a common measure of blood sugar over time – under control.
“Once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year,” Lilly’s senior vice president of product development, Jeff Emmick, said in a statement.
One trial, reported in The New England Journal of Medicine, involved patients with type 2 diabetes who were using insulin for the first time. A second trial in patients who had been using daily basal insulin degludec and a third trial in those who had been taking basal insulin glargine plus extra mealtime insulin doses were both reported in The Lancet.
Efsitora “has the potential to facilitate and simplify insulin therapy, reducing the hesitation often associated with starting insulin to treat type 2 diabetes,” Dr. Julio Rosenstock of University of Texas Southwestern Medical Center, who led one of the studies, said in a statement.
People newly diagnosed with type 2 diabetes usually start treatment with oral medications, but roughly one-third of them will need to use insulin within 8 years of their diagnosis, according to an editorial in The Lancet.
GENETICALLY ENGINEERED SKIN GRAFTS TREAT BLISTERING DISEASE
Long-lasting wounds from a painful genetic skin disease can be healed with skin grafts genetically engineered from a patient’s own cells, researchers reported in The Lancet.
In severe dystrophic epidermolysis bullosa, or EB, the skin is so fragile the slightest touch – even from clothing – causes blistering and wounds, eventually leading to large, open lesions that never heal.
“With our novel gene therapy technique, we successfully treated the hardest-to-heal wounds, which were usually also the most painful ones for these patients,” study leader Dr. Jean Tang of Lucile Packard Children’s Hospital Stanford in Palo Alto, California said in a statement.
Severe dystrophic EB is caused by a defect in the gene for collagen VII, a protein that normally holds the skin together. As a result, the layers of the skin separate in response to even slight friction.
To create the personalized skin grafts, doctors take a small biopsy sample of the patient’s un-wounded skin and introduce a corrected version of the collagen VII gene to the skin cells. These cells are then grown into sheets of healthy skin.
For the late-stage study, 11 patients with recessive dystrophic EB had a total of 43 wounds treated with grafts. For each treated wound, the researchers also identified a comparable “control” wound on the same patient that was managed with traditional measures.
Six months later, 81% of treated wounds were at least half healed, compared with 16% of control wounds. Roughly two-thirds of treated wounds were at least three-quarters healed, compared with 7% of control wounds, and 16% of treated wounds had completely healed, compared with none of the control wounds.
In addition, grafted areas had less pain, itching and blistering.
The same research team had previously developed a gene therapy gel for treating smaller EB wounds.
“I hope that if these patients are diagnosed as infants and start the gene therapy gel, maybe they won’t develop big wounds,” Tang said. “But if the gels don’t work and a wound does expand, the skin graft therapy is the right treatment. The life arc of their disease will, I hope, be modified, with less suffering.”
An editorial published with the study notes that EB patients who participated in early-stage trials of the skin grafts still had decreased blistering and wounding, pain, and itch at grafted sites five years later.
In April, the U.S. Food and Drug Administration granted Abeona Therapeutics approval for the skin grafts as an EB therapy.
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(Reporting by Nancy Lapid; editing by Bill Berkrot)
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