ENDO2020 Highlights: Diabetes

Technology accessibility in Type 1 diabetes differs by race and needs to be addressed to decrease health disparities

With Kathryn Fantasia MD, Edward Franek MD PhD, and Juan Pablo Frias MD

White people were given better access to technology for type 1 diabetes then BIPOC, even after accounting for socio-economic status, bringing attention to inequality in care.

Technology Use in Type 1 Diabetes Differs by Race

While clinical guidelines from the American Diabetes Association, the Endocrine Society and the American Association of Clinical Endocrinologists recommend the use of technology such as continuous glucose monitors (CGM) and continuous subcutaneous insulin infusion (CSII) among those with type 1 diabetes, data is limited among those getting care for type 1 diabetes in minority-serving, safety-net hospitals.

In a new study, Kathryn Fantasia MD, endocrinology fellow at Boston Medical Center and Boston University School of Medicine, found that the use of such technology was statistically significantly higher for white patients than all other groups except Asian patients.

Household income did not affect usage patterns, she said, in contrast to previous research. She concluded: "Given diabetes technology is a useful tool in reducing HbA1c and hypoglycemia, the barriers to accessing diabetes technology in non-Caucasian individuals should be addressed to decrease health disparities."

The information was drawn from 227 patients seen at her hospital from October 2016 through September 2017. While 55% of white patients used some form of technology, less than 30% of those of other races did, she found. Overall, 37% used some type of technology.

Use of the technology was associated with lower AICs. The overall mean A1C was 8.9%. For white patients it was 8.1%, for Black patients 10.1%, for Hispanic patients, 9.2%, and for all other patients 8.9% (P=0.0001).

Can Leptin Treatment Help De Novo Lipogenesis?

In another new study presented at ENDO2020, Annah Petek Baykal, a researcher at the National Institutes of Health, hypothesized that leptin treatment would decrease DNL by reducing insulin resistance and glycemia, leading to reduced circulating and hepatic triglycerides.

De novo lipogenesis or DNL plays a role in patients developing hepatic steatosis and non-alcoholic fatty liver disease (NAFLD). In patients with lipodystrophy, leptin decreases DNL, and reduced adipose tissue results in adipokine deficiencies, including lower plasma leptin, in turn contributing to insulin resistance, dyslipidemia, and ectopic accumulation of triglycerides.

Six months of metreleptin (Myalept, others) given to 11 patients (8.1mg/day) decreased DNL by 88%, to near-normal, and was linked with decreases in glycemia and improved peripheral and hepatic insulin sensitivity. After the treatment, percent of DNL decreased from 21% to 7% (p=0.0008) and absolute from 54.2 to 8.6 (p=0.003). HbA1c decreased, as did hepatic-TG and serum-TG. The bottom line: The research suggests treatment that targeted multi-organ insulin resistance may lead to a decrease in NAFLD and cardiovascular risk.

Dulaglutide: Safe for Older Patients?

Dulaglutide was also found superior to placebo in decreasing the incidence of major adverse cardiovascular events (MACE) in the broad patient population of the REWIND (Researching Cardiovascular Events with a Weekly Incretin in Diabetes) study. To determine the safety of the treatment in patients age 65 and above, researchers conducted a post-hoc analysis and compared outcomes in those under 65 years and those 65 and older.

Bottom line: The benefit in younger and older patients is similar, said researcher Edward Franek, MD, PhD, head of endocrinology and diabetology in the Central Clinic Hospital MSWiA and MMRC PAS in Warsaw, Poland.

The primary aim was to evaluate safety with regards to the occurrence of the composite safety outcome of overall mortality and severe hypoglycemia; a key secondary objective was to look at first occurrence of severe hypoglycemia. Of the 9,901 patients, 5,256 were 65 and above; 2,619 were on dulaglutide and 2,637 on placebo.  For those, the incidence of the composite safety outcome was 14.1% of those on the drug and 15.5% of those on placebo. Of the younger patients, the incidence of the composite safety outcome was 9.7% for drug-treated and 11% of the placebo-treated.

"Dulaglutide was superior to placebo in reducing the incidence of MACE," said Franek. "The hazard ratio was 0.88, giving a 12% reduction in the subgroup," he said.

As for safety and the secondary outcomes such as first occurrence of severe hypoglycemia, the researchers also found no significant differences.

The drug can be considered safe and effective in those 65 and over, he concluded.

Dulaglutide: Is More Better?

While the FDA-approved doses of dulaglutide, 0.75 and 1.5 milligrams once weekly, are effective for lowering glucose for those with type 2 diabetes, could higher investigational doses of 3 mg and 4.5 mg be even better? According to the 36-week results of Eli Lilly's phase III, randomized, double-blind, parallel-arm study, AWARD-11, yes.

The goal of lowering AIC is much needed, said study researcher Juan Pablo Frias, MD, medical director and principal investigator at the National Research Institute in Los Angeles. "We know up to half of patients treated with approved treatments for type 2 diabetes do not achieve their glycemic goals," he said.

The bottom line of his study: In patients with type 2 diabetes and insufficient glycemic control on metformin, increasing the dose to 3.0 mg or 4.5 mg provided more improvements in both glycemic control and weight loss, while maintaining an acceptable safety profile.

He reported on the 36-week results (the study went on for 52) in the three groups: those on the standard 1.5 mg (612), 3 mg (616), and 4.5 (614). All patients started on 0.75 dulaglutide for four weeks, then did dose escalation step wise every four weeks until they went to 1.5, 3, or 4.5.  Patients at baseline were on average 57, with a duration of type 2 diabetes of 7.6 years and an A1C of 8.6%. Body weight on average was 95.7 kilograms, with an average BMI of 34.2.

The higher doses were better at lowering A1C, with a reduction of 1.53% for 1.5 mg, 1.71% for 3 mg [p=0.003], and 1.9% for 4.5 mg [p<0.001]. Those achieving A1C below 7% were 57% on the 1.5mg, 65% on the 3.0 mg [p=0.006], and 71% on the 4.5mg [p<0.001]. Body weight change was higher with the 4.5 mg dose: 3.1kg with 1.5 mg, 4.0 kg with 3 mg [p=0.001], and 4.7 kg with 4.5mg [p=,0.001]. When they looked at the treatment-regimen estimand, not the efficacy estimand, the 4.5 mg dose was superior to 1.5mg, but the 3 mg dose did not achieve statistical significance.

More than half of those on the 4.5 mg dose achieved the sought-after weight loss of 5% or more.

If the higher doses are approved, "this would allow further dose escalation for patients not achieving their treatment targets with the 1.5-mg dose, without having to make a change in the treatment regimen (I.e., add another medication or switch medication)," Dr. Frias told Endocrine Web. In the future, if the higher doses are approved, it may provide a simple way to advance therapy in patients who aren't successful in achieving their glycemic goals with currently approved doses, he said.

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