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What additional medications might be best for patients taking metformin?
James Keagy 1975

What additional medications might be best for patients taking metformin?

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Diabetes

Johanna Taylor Katroscik, PharmD

Two recently published articles in the New England Journal of Medicine looked at the comparative efficacy of different medications for the treatment of type 2 diabetes.

Researchers hoped to learn more about what drug(s) might be the best addition for patients who are already taking metformin. They examined the difference in efficacy of the addition of insulin glargine, liraglutide, sitagliptin, and glimepiride when added to a metformin regimen, and found that patients who received insulin glargine or liraglutide had lower HbA1C levels than patients who received glimepiride or sitagliptin.

The patients who received insulin glargine or liraglutide were also less likely to have HbA1C levels greater than 7% than patients who received glimepiride or sitagliptin. For secondary outcomes, there were no significant differences between treatment groups.

Unfortunately, the trial did not include sodium-glucose cotransporter-2 (SGLT-2) inhibitors, one of the current pillars of guideline-directed therapy.

Trial design and overview

Researchers were looking at a primary outcome of the amount time it would take patients to reach an HbA1C level of greater than 7% while on a dual therapy regimen. The secondary outcome was the amount of time it would take patients to reach an HbA1C level of greater than 7.5% while on dual therapy.

Other outcomes were published in a companion article. In the companion article, researchers wanted to know if there was a difference in incidence of microvascular or cardiovascular outcomes such as hypertension, dyslipidemia, albuminuria, and reduced eGFR.

The trial—The Glycemia Reduction Approaches in Type 2 Diabetes: A Comparative Effectiveness (GRADE) Study—was a randomized, multicenter, parallel group, comparative efficacy trial that enrolled 5,047 participants and followed them for a mean of 5 years. Key inclusion criteria were that patients must have had a diagnosis of type 2 diabetes for less than 10 years and had to have been diagnosed with diabetes when they were 30 years or older (20 years or older for Native Americans).

Additionally, patients were required to have HbA1C levels between 6.8% and 8.5%, taking a minimum daily dose of 1,000 mg of metformin when the trial started, and willing to self-administer daily subcutaneous injections.

Exclusion criteria were numerous and included patients who had been taking metformin for more than 10 years prior to randomization; current or previous use of other blood-glucose–lowering medications; patients who had a major cardiovascular event within the previous year prior to randomization; previous organ transplant, liver failure, reduced kidney function; and more.

Potential impact on practice

The study left out a key treatment option for patients who have been diagnosed with diabetes: SGLT-2 inhibitors. The reason for this exclusion from the trial was that at the time the study was initiated, SGLT-2 inhibitors had not yet gained FDA approval.

SGLT-2 inhibitors are one of the key medication recommendations in the 2022 Standards of Medical Care in Diabetes published by the American Diabetes Association. This raises an issue when trying to utilize the data from this study because it is not a true comparison of all potential therapies.

Additionally, this study had extensive exclusion criteria, and other studies have been done since that do show a benefit for certain patients with some of the conditions excluded in this trial, particularly patients with cardiovascular and/or renal issues.

While this study was not able to assess all medications or drug classes, it did show that all patients who received an additional glucose-lowering therapy with metformin experienced reduced HbA1C levels.

What additional medications might be best for patients taking metformin?

It also showed that patients who received insulin glargine or liraglutide were able to achieve and maintain lower HbA1C levels when compared with patients who were on glimepiride or sitagliptin.

Although the study did not necessarily show pharmacists anything they might not already know, it does provide pharmacists more data to justify certain clinical decisions.

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