Highlights reported by MedPage Today earlier in the week included the prevention of new-onset diabetes with dapagliflozin, safety of ertugliflozin for the heart in type 2 diabetes patients, and slashed rates of ketoacidosis with continuous glucose monitoring.
The meeting also reported updates in diabetes care from three other trials: T1GER, REDUCE-IT, and SENZA-PDN. Here are brief summaries.
The T1GER Study
The use of golimumab (Simponi) in children with newly diagnosed, stage 3 type 1 diabetes preserved beta cell function and reduced insulin use, according to a phase II analysis of the T1GER study.
Children and young adults treated with golimumab had better average 4-hour C-peptide area under the curve (AUC) than those in the placebo group — 0.64 and 0.43 pmol/mL, respectively — reported Teresa Quattrin, MD, of the University of Buffalo in New York.
There was also reduced insulin use among patients who took golimumab, with the dose increasing an average of 0.24 units per kilo per day in the placebo group, versus just 0.07 units per kilo per day among those who received the intervention.
After 1 year of treatment, nearly 43% of trial participants who received golimumab were in partial remission, compared with 7% in the control group, Quattrin said.
“The intervention was able to achieve preserved beta cell function,” she told MedPage Today. “This is not meant to be a cure; this is a way to arrest the disease progression.”
The double-blind study included 84 children and young adults ages 6 to 21 with stage 3 type 1 diabetes.
Aside from lower insulin use, patients treated with golimumab had decreased rates of hypoglycemia and proinsulin and C-peptide ratios compared with those in the placebo group. In addition, the intervention was well tolerated and had no new safety signals, the researchers reported.
“Any agent and any effort that can prolong the life of the beta cell function and make the lifestyle of these children less burdensome, is very relevant from a clinical standpoint,” Quattrin said.
REDUCE-IT DIABETES
In the REDUCE-IT DIABETES trial, use of icosapent ethyl (Vascepa) in diabetes was associated with a reduced risk of major adverse cardiovascular events.
Patients who took icosapent ethyl who had both diabetes and established cardiovascular disease at baseline had a 7% absolute risk reduction for the first ischemic event, and a 12.7% reduction for total events, according to Deepak Bhatt, MD, MPH, of Brigham and Women’s Hospital in Boston.
Relative risk for the primary endpoint — cardiovascular death, myocardial infarction, stroke, coronary revascularization, or unstable angina — dropped 23% among patients treated with icosapent ethyl, compared with those in the placebo group (RR 0.77, 95% CI 0.66-0.88).
For the secondary endpoint — cardiovascular death, myocardial infarction, or stroke — there was a 30% relative risk reduction, Bhatt said.
“In the placebo arm, we still see a high risk, which is reduced substantially with icosapent ethyl,” he told MedPage Today. “We have an opportunity to reduce not just the first, but also recurrent ischemic events.”
SENZA-PDN
Adults with painful diabetic neuropathy who received spinal cord stimulation therapy had lower pain scores and improved quality of life, according to preliminary data from the SENZA-PDN trial.
After 3 months, 79% of patients who had painful diabetic neuropathy and received 10 kHz spinal cord stimulation therapy met the primary endpoint of no worsening neurological function and a pain score cut in half compared with 5% of participants who had conventional medical management alone, reported Erika Petersen, MD, of the University of Arkansas for Medical Sciences in Little Rock.
Participants in the stimulator arm saw improvements in pain score, neurological function, and quality of life:
- The visual analog scale for lower limb pain intensity dropped from 7.6 to 1.7 cm in the stimulator arm, compared with 7.0 to 6.5 cm among those who received conventional medical management
- About 72% of patients on a stimulator experienced sensation mapping improvement in a monofilament and pinprick exam, compared with 7% in the conventional management group
- Patients saw improvements in sleep quality, work and social-related stresses, and overall satisfaction
She explained that spinal cord stimulation is a fairly minimally invasive procedure, involving a battery pack underneath the skin and wires that travel into the spinal cord and block pain messages from being sent to the brain.
The randomized controlled SENZA-PDN trial included 216 patients assigned to either 10 kHz spinal cord stimulation therapy with conventional medical management, or conventional methods alone. Participants included patients with painful diabetic neuropathy symptoms for more than a year, lower limb pain intensity greater than 5 cm, hemoglobin A1c less than 10%, and an upper limb pain intensity less than 3 cm.
The initial 3-month results showed improvements in pain score and quality of life for patients with spinal cord stimulation, Petersen said. “The use of spinal cord stimulation in a diabetic population seems to be effective, and it’s also safe.”
Disclosures
Quattrin and colleagues disclosed financial relationships with
Janssen Pharmaceuticals; Provention Bio Inc.; Johnson & Johnson; and
SAB Biotherapeutics.
Bhatt and colleagues reported funding to Brigham and Women’s Hospital from Amarin Corporation for the REDUCE-IT trial, as well as financial relationships with AstraZeneca, Bayer, Lilly Diabetes, Novo Nordisk, and others.
Petersen and colleagues disclosed financial relationships with Neuros Medical, Nevro, Abbott, Medtronic, and others.
Bhatt and colleagues reported funding to Brigham and Women’s Hospital from Amarin Corporation for the REDUCE-IT trial, as well as financial relationships with AstraZeneca, Bayer, Lilly Diabetes, Novo Nordisk, and others.
Petersen and colleagues disclosed financial relationships with Neuros Medical, Nevro, Abbott, Medtronic, and others.
Primary Source
ADA 2020
Secondary Source
ADA 2020
