Fans of diabetes clinical trials rejoice: The American Diabetes Association (ADA) 2017 Scientific Sessions is your meeting.
Of course, the annual ADA conference always offers cutting-edge research on just about every aspect of diabetes for scientists, clinicians, other professionals, patients, and financial stakeholders. But this year, the number of major clinical trial results — in both type 2 and type 1 diabetes — is especially notable if not record-setting, ADA chief scientific and medical officer William T Cefalu, MD, told Medscape Medical News.
"I've never seen a more packed scientific sessions as far as things I want to see and exciting new research," the Louisiana endocrinologist said.
Type 2 Diabetes Trials: More CV Outcomes
Perhaps the most anxiously awaited of the major trials will be the cardiovascular-outcomes trial for the sodium glucose cotransporter-2 (SGLT2) inhibitor canagliflozin (Invokana, Janssen Pharmaceuticals), the Canagliflozin Cardiovascular Assessment Study (CANVAS). The 2-hour session on June 12 will include results from the sibling trials CANVAS and the CANVAS renal-end-points trial (CANVAS-R), both sponsored by Janssen Research & Development.
Since the landmark 2015 EMPA-REG trial demonstrated a major reduction in both all-cause and cardiovascular death among high-risk patients taking another SGLT2 inhibitor, empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), the diabetes community has debated whether that survival benefit is a class effect.
Results from CANVAS and CANVAS-R could help answer that question. "I think a lot of people will be interested in that," Dr Cefalu said, adding, "I'll be looking to see if this is a class effect or if it's selective for one particular agent in the class-
This is a study that could actually alter and inform clinical decision making if it's positive."
In addition to the cardiovascular and renal results, the CANVAS data may also provide additional information about safety concerns, including diabetic ketoacidosis, which has been reported with all SGLT2 inhibitors, and both increased fracture and amputation risksreported with canagliflozin specifically.
"The important thing to note here," Dr Cefalu said, is "we know that at least one of this class has a favorable cardiovascular benefit, which has to be weighed against any risks, as with any medication."
Another major randomized trial involving type 2 diabetes, also to be presented in an hour-long session on Monday, is Novo Nordisk's DEVOTE, comparing the cardiovascular safety of the long-acting insulin degludec (Tresiba) vs insulin glargine (Lantus, Sanofi) in high-risk patients.
Dr Cefalu commented, "We know from the [Outcome Reduction with an Initial Glargine Intervention (ORIGIN)] trial that glargine was neutral on cardiovascular end points. Now, with another long-acting insulin, the question is whether they are equal on cardiovascular outcomes and if so, what is the benefit of one vs the other regarding hypoglycemia and other risks. This is interesting because it's a head-to-head study of two basal insulins [and effects] on cardiovascular disease."
Type 1 Diabetes Trials: Treatment and Possible Prevention
A special 2-hour symposium on Sunday afternoon will be devoted to the Reducing With Metformin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL) international multicenter trial, sponsored by the JDRF. Enrolling patients with type 1 diabetes aged 40 and older, the study's primary end point is progression of carotid intima-media thickness at 3 years.
"There is residual [cardiovascular] risk with type 1 despite all the advances in therapy. If metformin really has a beneficial effect, I think that would be incredibly important," Dr Cefalu commented.
And on the prevention side, results of three major trials will be presented in one 2-hour session Monday afternoon, all looking at whether intervention in the earliest stages of type 1 diabetes — either new-onset or antibody positivity — can slow or prevent progression to full insulin dependence.
The three trials are the Type 1 Diabetes TrialNet Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus (National Institutes of Health), Imatinib in New-Onset Type 1 Diabetes (University of California, San Francisco, and JDRF) and DIABPREV-IT trial with glutamic acid decarboxylase (GAD) vaccine (Lund University)
Of the TrialNet study, Dr Cefalu said, "If it's positive, it will be fantastic. If it's negative, hopefully, it will inform us." Overall, he said, "These are three type 1 prevention trials being presented at the same symposium, which will be very exciting. If any one of these trials turn out, it could move us toward more translational results."
Lipid-Lowering in Both Diabetes Types
Yet another major clinical trial, being presented on Sunday morning, involves the use of alirocumab (Praluent, Sanofi/Regeneron) in both type 1 and type 2 diabetes: Sanofi's Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM–Insulin).
Results for that will be presented, along with a discussion of the Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM–Dyslipidemia).
Together, the two ODYSSEY studies are the first to examine the effect of a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor on safety, tolerability, and glycemia in addition to lipid management exclusively in diabetes populations.
The President's Oral Abstracts: A Potpourri
Of the eight oral abstracts selected from among hundreds to be presented Tuesday morning in a special President's Oral Abstract session, the more clinical ones include a comparative-effectiveness trial of major depression treatment in type 2 diabetes, a look at heart-failure hospitalization among new users of SGLT2 inhibitors, a trial of a human glucagon receptor antibody for improving glycemic control in type 1 diabetes, and efficacy and safety of oral basal insulin in type 2 diabetes.
Politics a' Plenty
For attendees who seek some politics with their medical science, there are several agenda items: A symposium on Saturday morning and oral abstract session on Monday morning addressing the impact of the Affordable Care Act (ACA) — and its possible successor — on people with diabetes, and a sure-to-be-feisty discussion Saturday afternoon on the rising cost of insulin.
Dr Cefalu declined to comment on that aspect of the meeting, noting, "I'm going to wait and see what happens. It seems to change every day."
"A Wealth of Riches"
Of course, all of the above is just a tiny fraction of the hundreds of symposia, current-issues sessions, oral abstracts, posters, professional interest group sessions, special lectures and addresses, and posters covering every imaginable aspect of diabetes science and care delivery, much of it overlapping throughout the four and a half days.
"For me, it seems like there's so much exciting science. It's going to be hard to pick which sessions to go to," Dr Cefalu said. "There are so many things I want to see at the same time. It's a wealth of riches here."
Dr Cefalu is an employee of the American Diabetes Association. He has no further relevant financial relationships.
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