New data from cardiovascular prevention trials are just some of the highly anticipated study announcements that will be presented at the 79th Scientific Sessions. Here’s the schedule of sessions featuring major study results.
Friday, June 7
11:30 a.m. – 12:30 p.m.
The Vitamin D and Type 2 Diabetes (D2d) Study—A Multicenter Randomized Controlled Trial for Diabetes Prevention
S-157 (South, Upper Mezzanine Level)
Results will be unveiled from the Vitamin D and type 2 diabetes (D2d) study, the largest-ever clinical trial specifically designed to answer the question of whether vitamin D supplementation delays the onset of diabetes for those at risk. The results of the study, which launched in 2013, have significant public health implications, given the significant number of people at risk and the very low cost of the intervention.
Saturday, June 8
1:45 p.m. – 3:45 p.m.
Longitudinal Outcomes in Youth with Type 2 Diabetes—The TODAY2 Study
S-154 (South, Upper Mezzanine Level)
TODAY2 is a post-intervention follow-up to the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) Study, with a primary objective of tracking the progression of T2D and related comorbidities and complications as the participants transition to young adulthood. Data from this cohort now allows the TODAY Study Group to report on extensive experience in the development of renal, cardiac, eye, and nerve complications, as well as data on pregnancy outcomes and health care utilization in this vulnerable population.
4:00 p.m. – 6:00 p.m.
PREVIEW Study Results—Prevention of Diabetes through Lifestyle Intervention and Population Studies around the World
S-203 (South, Level 2)
The PREVention of diabetes In Europe and around the World (PREVIEW) study is the first diabetes prevention study to use total meal replacements (to induce ≥8 percent weight loss in eight weeks) and then compare two diets of different composition (high vs. moderate protein, moderate vs. low glycemic index) and two physical activity strategies of different intensity for weight loss maintenance. The findings suggest that it’s possible to cost-effectively prevent type 2 diabetes in most individuals at high risk.
Sunday, June 9
8:00 a.m. – 10:00 a.m.
TrialNet—New Therapeutic Approaches and Insights for Type 1 Diabetes
S-153 (South, Upper Mezzanine Level)
Where are we with disease-modifying therapy in type 1 diabetes? This session will present clinical and mechanistic results from TrialNet’s landmark Teplizumab Prevention Trial in individuals with multiple antibodies and abnormal glucose tolerance. The question for this study is whether treatment at early stages of disease can delay progression to clinical (stage 3) type 1 diabetes. Two-year clinical results from TrialNet’s Low Dose ATG and GSCF trial in new-onset diabetes will also be presented, as well as mechanistic data from TrialNet’s Natural History and Immune effects of Oral Insulin studies.
12:00 p.m. – 1:00 p.m.
Results and Comparisons from the RISE Clinical Trial—Adult Medication Study
S-157 (South, Upper Mezzanine Level)
Restoring Insulin Secretion (RISE) is a group of three studies, which includes the Adult Medication Study. In this study, adults with impaired glucose tolerance or recently diagnosed type 2 diabetes not receiving any medications have been randomized to one of four intervention groups to determine whether it’s possible to slow the loss of islet beta-cell function. Study results will be compared to youth with the same glucose tolerance abnormalities and thus highlight similarities and differences in the pathogenesis of the disease in the two age groups, as well as the response to interventions aimed at preserving beta-cell function.
2:15 p.m. – 4:15 p.m.
DECLARE-TIMI 58 Trial
W-3001 (West, Level 3)
The Dapagliflozin Effect on Cardiovascular Events (DECLARE-TIMI 58) trial is the first cardiovascular outcome study to enroll a large cohort of diabetes patients with risk factors for atherosclerotic cardiovascular disease (ASCVD) and a large cohort of diabetes patients with known ASCVD. The session will cover the primary endpoints as well as subanalyses, including extensive discussion on renal endpoints and an in-depth review of the multiple safety aspects of dapagliflozin explored in the trial.
4:30 p.m. – 6:30 p.m.
Once-Weekly Dulaglutide and Major Cardiovascular Events—Results of the REWIND Trial
W-3001 (West, Level 3)
There have been five large, published randomized control trials on the effect of GLP-1 receptor agonists in patients with type 2 diabetes who have had a cardiovascular event and who also have a high prevalence of cardiovascular disease at baseline. The Researching CV Events with a Weekly Incretin in Diabetes (REWIND) trial was designed to test the long-term cardiovascular effect of the GLP-1 receptor agonist dulaglutide in a lower-risk group of 9,901 people, who are more representative of those in a general practice with type 2 diabetes.
Monday, June 10
4:30 p.m. – 6:30 p.m.
The CAROLINA Trial—First Results of the Cardiovascular Outcomes Trial Comparing Linagliptin vs. Glimepiride
W-3001 (West, Level 3)
CAROLINA (Cardiovascular Safety of Linagliptin) is the longest cardiovascular outcome trial to date and the only one with a head-to-head active comparator design, testing in a randomized, double-blind fashion the cardiovascular (CV) safety of a DDP-4 inhibitor (linagliptin) versus a sulfonylurea (glimepiride). The results of the CAROLINA Trial have the potential to provide meaningful CV and clinical evidence to better base the decision-making process when selecting a second- or third-line therapy to metformin. The trial may also provide critical new evidence to inform the highly debated issue of the CV safety of sulfonylureas.
Tuesday, June 11
7:30 a.m. – 9:30 a.m.
CREDENCE and CARMELINA—Results from Two Major Clinical Trials in Kidney and Cardiovascular Disease in Diabetes
N-Hall E (North, Exhibition Level)
The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial is the first randomized, double-blind clinical outcome trial specifically designed and powered to assess the effects of an SGLT2 inhibitor (canagliflozin) compared to placebo on major kidney outcomes. Data from CREDENCE could have substantive impact on clinical practice for type 2 diabetes patients at high renal risk. Cardiovascular and Renal Microvascular outcome study with Linagliptin in Patients with Type 2 Diabetes Mellitus (CARMELINA) evaluated the CV safety and kidney outcomes of linagliptin in type 2 diabetes patients at high CV risk enriched with chronic kidney disease.
9:45 a.m. – 11:45 a.m.
Oral Semaglutide—The PIONEER Program Trials
N-Hall E (North, Exhibition Level)
The goal of the PIONEER program is to demonstrate the safety and efficacy of an oral formulation of semaglutide. The PIONEER trial program enrolled more than 8,000 people with type 2 diabetes in 10 global clinical trials. Subjects were prescribed oral semaglutide on an empty stomach first thing in the morning. GLP-1 receptor agonists such as semaglutide are powerful glucose-lowering drugs that do not cause hypoglycemia and are associated with weight loss. Furthermore, the class seems to be associated with improvements in cardiovascular risk in patients with pre-existing cardiovascular disease. However, many patients do not benefit from these drugs because they are injected and, as a result, often are not selected early in the course of the disease.