Could combos replace basal-bolo insulin in type 2 diabetes?

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For patients with type 2 diabetes who take multiple daily insulin injections, switching to combination treatment with basal insulin plus an agent from one of the two most recent classes of glucose-lowering drugs may offer a more comfortable and safer alternative, a new randomized study indicates.

The study shows that switching patients from basal insulin-bolo (BBI) regimens (four injections a day) to a fixed once-daily combination of basal insulin plus a glucagon-like peptide 1 receptor agonist (agonist GLP-1) or a daily oral inhibitor of sodium-glucose cotransporter 2 (SGLT2 inhibitor) produced comparable glycemic control but with lower insulin doses, fewer injections, and less hypoglycemia.

Due to the progressive loss of beta cell function in patients with type 2 diabetes, the use of insulin is often required. Currently, about a quarter of people with type 2 diabetes receive it insulin therapy, however, only 50% of these individuals achieve a goal A1c level <7%. L'American Diabetes Association aconsella considerar la intensificació de la teràpia amb insulina injectable quan la dosi basal és> 0.5 units / kg / di A1c remains above target.

However, the new data “seem to refute the dogma about the untouchability of the BBI regimen in type 2 diabetes by providing evidence that it is possible and safe to switch from a BBI regimen to a combined fixed injection once a day or once a day the pill of glyphlozin added to basal insulin, ”says Dario Giugliano, MD, PhD, University of Campania, Naples, Italy, and colleagues in his article, which was published online April 21 a Diabetes care.

“This simplification strategy may work, in terms of significant and clinically relevant reduction in A1c, in many patients who maintain their results for at least 6 months,” they point out, and “the addition of a test drug cardiorenal benefits it can be seen as another potential merit of the combination strategy. “

If the results continue beyond the 6-month trial period, Giugliano and colleagues say, “they will facilitate the role of the physician, be appreciated by the patient, and hopefully provide better guidance to professionals in choosing medicines “.

“Really important work”: the approach could combat “basalization”

Rozalina G. McCoy, a physician, endocrinologist and primary care clinic at the Mayo Clinic in Rochester, Minnesota, asked me to comment, and defined the study as “really important work.”

She said Medscape Medical News who often see patients receiving basal insulin, but instead of premeal insulin, their basal dose has been continually increased to the point of “sobbasalization,” which does not cover the food consumed, but at the same time can cause hypoglycemia.

“So if we keep increasing the basal, it’s a problem, but it’s too basal or they end up on a complex regimen with four injections a day,” he said.

Instead, he said, “I think what this study really shows is that if we use GLP-1 agonists or SGLT2 inhibitors along with basal insulin, we can effectively cover some of their needs during meals without having hypoglycemia, increasing weight, and MDI treatment load [multiple daily injection] therapy “.

However, he noted, “This is a short, 6-month study. The big question is, how long do we buy? Many patients with type 2 diabetes will ultimately need multiple daily insulin injection therapy. but the hope and where I think this study comes in, is to delay it as much as possible. “

Reduced glucose equivalent, fewer injections, less hypoglycemia

The study included 305 adults over the age of 35 with type 2 diabetes whose A1c levels were> 7.5% with multiple daily basal-bolo injection therapy (four injections per day).

They were randomly assigned to receive intensification of the current basal-bolo regimen, a fixed combination of basal insulin plus a GLP-1 agonist (IDegLira or IGlarLixi), or basal insulin plus an SGLT2 inhibitor (either canagliflozin, dapagliflozin, or empagliflozin). Of the 305 patients, 100%, 88%, and 91%, respectively, completed the study.

The main result, the changes in A1c with respect to the initial value at 6 months, were -0.6, -0.6 and -0.7 percentage points, respectively (Pg = .356) for BBI, the GLP-1 agonist combination and the SGLT2 inhibitor combination. The proportion of patients who reached A1c levels of ≤7.0%, ≤7.5% and ≤8.0% did not differ significantly between the three groups (Pg = .189), with no inferiority for the two combinations compared to the basal bolo (Pg <.001 for both).

Daily insulin doses increased in the basal-bolo group and decreased in the two combined groups (superiority, Pg <.01 for both). Patients in the fixed group of GLP-1 agonist combination experienced significant weight loss compared with the other two groups (-1.9 kg vs -0.6 kg for the combination of SGLT2 inhibitors and a gain of 0 , 3 kg with BBI; Pg <.001, Pg = .855 i Pg = 0.159, respectively).

The proportions that experienced at least one episode of level 1 hypoglycemia (<70 mg / dL with symptoms / signs) were 17.8%, 7.8%, and 5.9% for basal bolo, the fixed agonist combo of GLP-1 and SGLT2 inhibitor combination, respectively. (Pg = 0.015). Less than 5% of patients in any group experienced level 2 (<54 mg / dL) or level 3 (<50 mg / dL or need help) hypoglycemia.

The approach could help prevent therapeutic inertia in primary care

McCoy said he doesn’t usually use the combined products of basal insulin-fixed-dose basal insulin-GLP-1 because they don’t allow as much flexibility as giving the agents separately. “With fixed combos, you won’t get as many benefits as you can, because you limit how much you can give,” he said.

However, he said, “the principle of basal insulin plus the GLP-1 agonist or SGLT2 inhibitor is really important because, in any case, it will help prevent this dead end of basal insulin therapy in the primary care.

“It’s really difficult for the primary care provider to start MDI therapy. It requires a lot of patient education and close follow-up … We hope this helps with some of these therapeutic inertias.”

The study was funded in part by the Associazione “Salute con Stile”, Naples, Italy. Giugliano received fees for speaking at meetings of Novartis, Sanofi, Eli Lilly and Company, AstraZeneca and Novo Nordisk. McCoy is funded by the National Institutes of Health.

Diabetes care. Published online April 21, 2021. Summary

Miriam E. Tucker is a freelance journalist based in the Washington, DC area. She is a regular contributor to Medscape. Other of his work has appeared in the Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. It can be found on Twitter @MiriamETucker.

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