Study Looks at Managing New T2D Patients

A closer look at metformin monotherapy

With today’s emphasis on population health and early and aggressive interventions for patients with diabetes, physicians are charged with closely monitoring newly diagnosed patients.

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It was with this in mind that Cleveland Clinic endocrinologists Kevin Pantalone, DO, and Robert Zimmerman, MD, set out to take a closer look at metformin monotherapy for newly diagnosed type 2 diabetes (T2D) patients. The study was titled Intensification of Therapy and Time until A1C Goal Attainment among Patients with New-onset Type 2 diabetes Who Fail Metformin Monotherapy within a Large Integrated Health System.

Dr. Pantalone presented results of this study on behalf of his research group at the American Diabetes Association’s 76th Scientific Sessions in New Orleans on June 13.

“We all think we’re doing a great job monitoring our patients, but when we look at the data, clearly we can do better – this goes for specialists and primary care physicians,” says Dr. Pantalone.

In the study, Cleveland Clinic’s electronic health record was used to identify patients with newly-diagnosed T2D between 2005 and 2013 who failed to reach their A1C goal after three months of metformin monotherapy. In the study, a time-dependent survival analysis was used to compare the time until A1C goal attainment in patients who receive early intensification of therapy (within six months of metformin failure) or late intensification. The analysis was performed for A1C goals of 7% (N=1,168), 7.5% (N=679), and 8% (N=429).

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“Clinical inertia” has been used to describe the delay in the intensification of type-2 diabetes treatment among patients with poor glycemic control. Previous studies may have exaggerated the prevalence of clinical inertia by failing to adequately monitor drug dose changes and non-medication interventions. The goal of this project was to evaluate the intensification of diabetes therapy and hemoglobin A1C (A1C) goal attainment among patients with newly-diagnosed T2D who fail metformin monotherapy. Interventions included the addition of anti-diabetic medication, prescription for a weight loss medication, change in metformin dose or regimen, or referral to a dietitian or nutritionist.

Results showed that treatment was intensified early in 62%, 69%, and 72% of patients when poor glycemic control was defined as an A1C >7%, >7.5%, and >8%, respectively. The probability of undergoing an early intensification was greater the higher the A1C category. And time until A1C goal attainment was shorter among patients who received early intensification regardless of the A1C goal (all P<0.05).

In conclusion, the results demonstrate that a substantial number of patients with newly-diagnosed T2D fail to undergo intensification of therapy within six months of metformin monotherapy failure. Early intervention in patients who fail metformin monotherapy resulted in more rapid attainment of A1C goals.

Dr. Pantalone notes that recent ADA and American Association of Clinical Endocrinologists (AACE) guidelines have been emphasizing early and aggressive intensification. “After patients are initiated on a regimen of metformin and lifestyle modification, we should be checking the A1C within three months and intensifying therapy in those who are still not at goal,” says Dr. Pantalone. Generally, this is an A1C of < 7%.

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The data show that over a third of newly diagnosed T2D patients failing at least three months of metformin therapy failed to have an intervention within six months of the elevated A1C (>7%), despite an intervention being indicated.

Dr. Pantalone says “this is worrisome,” as further analysis of the data demonstrated that the likelihood that a patient gets there A1C to goal is more likely if they undergo an early intervention (within six months) of the elevated A1C, vs. a late intervention (>6 months or never).

Simply put, Dr. Pantalone says we wanted to know how we are doing. What remains to be seen is if this early and aggressive intervention actually translates into improvements and clinical outcomes, not just an A1C goal attainment. This will be the topic of future research.

Disclosure: This study was sponsored by Merck. Drs. Pantalone and Zimmerman also receive consulting and speaking fees from the company.