Top News from ADA 2018

All The Most Important News and Updates form the American Diabetes Association’s 78th Scientific Sessions – ADA 2018

Two-year Data from ViaCyte’s STEP ONE Clinical Trial

June 23, 2018

ViaCyte, Inc., a privately-held regenerative medicine company, has announced two-year data from Cohort 1 of the ongoing Safety, Tolerability, and Efficacy of VC-01™ (PEC-Encap™) Product Candidate in Type One Diabetes (STEP ONE) clinical trial.  The PEC-Encap combination product candidate consists of stem cell-derived pancreatic progenitor cells (PEC-01) encapsulated in a delivery device called the Encaptra® Cell Delivery System.  The results indicate that the PEC-Encap product candidate, delivered at a sub-therapeutic dose, has to date been safe and well tolerated.  The Encaptra Cell Delivery System appears to protect the implanted cells from allo- and auto-immune rejection and the patients from sensitization.

Ozempic® provided greater weight reductions for adults with a baseline BMI of or above 25 kg/m2 than those with lower baseline BMI <25 kg/m2, in a SUSTAIN 7 post-hoc analysis

23 June 2018 ­

Ozempic® (semaglutide) 0.5 mg or 1.0 mg provided greater weight reductions vs dulaglutide 0.75 mg or 1.5 mg, respectively, in adults with type 2 diabetes, regardless of baseline body mass index (BMI), with the greatest reductions occurring in adults with a baseline BMI >25 kg/m2. While the primary endpoint of SUSTAIN 7 was change in HbA1c, this post-hoc exploratory analysis examined the secondary endpoint of change in body weight by baseline BMI.

Zealand Pharma presented two dasiglucagon milestone studies

June 23, 2018

Zealand Pharma has announced results from two studies on dasiglucagon. According to Zeland dasiglucagon has the potential to create a paradigm shift in the treatment of people with insulin dependent diabetes using an automated artificial pancreas system. Dasiglucagon is a novel analog of glucagon that is stable in an aqueous formulation at body temperature and thus requires no reconstitution.

Tresiba® demonstrated significantly improved blood sugar control and lower rates of hypoglycaemia versus insulin glargine U300 in real-world evidence study

23 June 2018

Findings from CONFIRM – a large real-world evidence (RWE) study comparing the effectiveness of Tresiba® (insulin degludec injection) versus insulin glargine U300 – were presented at ADA in Orlando. The retrospective, non-interventional comparative effectiveness study, which included more than 4,000 adults with type 2 diabetes who were starting basal insulin for the first time, showed that after six months those treated with Tresiba® had significantly lower HbA1c compared to those treated with insulin glargine U300 (-1.5% vs. -1.2% respectively; p=0.029).

Fractyl Announces Presentation of Key Scientific Research Indicating That Modern Diets Durably Alter Duodenal Lining, Highlighting the Intestine’s Role in Type 2 Diabetes and NASH

June 23, 2018

Fractyl Laboratories Inc. has announced the presentation of breakthrough research providing the first clear mechanistic link between modern diets and their causal effect on the pandemics of insulin resistance, obesity, and metabolic diseases. In an animal model, a modern diet high in fat and sugar caused overgrowth of the duodenal mucosa and overexpression of key gut hormones from the duodenum, the first segment of the intestine. These findings suggest a role of the duodenum in insulin resistance and metabolic diseases. The results also provide a rational explanation for the remarkable, weight-independent metabolic benefits of bariatric surgeries that bypass the duodenum.

New Data Show Amgen’s Repatha® (evolocumab) Significantly Reduced LDL-C and Non-HDL-C in High-risk Patients With Type 2 Diabetes

June 23, 2018

Amgen has announced new data that show Repatha® (evolocumab) significantly reduced low-density lipoprotein cholesterol (LDL-C) and non-high density lipoprotein cholesterol (non-HDL-C) in patients with Type 2 diabetes and hypercholesterolemia or mixed dyslipidemia, taking the maximum tolerated dose of moderate/high-intensity statin therapy. BANTING was a dedicated study evaluating the efficacy of Repatha (monthly dosing), in lowering LDL-C and improving other lipid levels in patients with Type 2 diabetes. In addition to meeting criteria for hypercholesterolemia or mixed dyslipidemia, patients in the trial had varying degrees of glycemic control.

Oral semaglutide demonstrated significant reduction in blood sugar vs placebo in PIONEER 1 trial

June 23, 2018 ­

Oral semaglutide, an investigational GLP-1 analogue taken as a once-daily tablet, achieved significant reductions in blood sugar versus placebo in adults with type 2 diabetes, according to findings from the PIONEER 1 phase 3a trial. The trial evaluated the efficacy and safety of 3, 7 and 14 mg oral semaglutide compared with placebo as monotherapy over 26 weeks in adults with type 2 diabetes.

Jardiance® reduced risk of kidney disease progression in adults with type 2 diabetes and established cardiovascular (CV) disease independent of control of conventional CV risk factors

June 23, 2018

Boehringer Ingelheim and Eli Lilly and Company have announced findings from two new analyses of the landmark EMPA-REG OUTCOME® trial. Results include a post-hoc analysis demonstrating consistent effects for Jardiance® versus placebo on renal outcomes in patients with established cardiovascular (CV) disease and type 2 diabetes, irrespective of control of certain CV risk factors.

Lexicon Pharmaceuticals Announces Positive 52-week Results from Sotagliflozin inTandem1 Study Presented at ADA 2018 and Published in Diabetes Care

June 24, 2018

Lexicon Pharmaceuticals, Inc. has announced positive 52-week results from the Phase 3 inTandem1 study for sotagliflozin in adults with type 1 diabetes. In the North American study, administration of sotagliflozin 200 mg or 400 mg in combination with maximally tolerated standard of care insulin therapy resulted in statistically significant reductions in A1C levels and weight compared to optimized insulin alone. A lower incidence of severe hypoglycemia was observed with sotagliflozin 200 mg and 400 mg compared to placebo.

Real-World Data Show Advantages in People Treated with Lilly’s Once-Weekly Trulicity® (dulaglutide) Compared to Those Treated with Liraglutide and Exenatide QW

June 24, 2018

People with type 2 diabetes new to treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist (RA) had better blood sugar control, were more likely to adhere to treatment and stayed on treatment longer with once-weekly Trulicity® (dulaglutide) compared to once-daily liraglutide and once-weekly exenatide QW according to real-world data. Trulicity is Eli Lilly and Company’s once-weekly, injectable GLP-1 RA approved to improve blood sugar (glucose) in adults with type 2 diabetes.

AstraZeneca shared latest data from an industry-leading portfolio that aims to advance clinical understanding of diabetes and CV risk management

June 24, 2018

AstraZeneca and its global biologics research and development arm, MedImmune, presented 45 abstracts including seven late-breaking data disclosures from the Company’s Cardiovascular, Renal & Metabolism (CVRM) therapy area. This latest research will help to inform clinical practice with Farxiga (dapagliflozin) and Bydureon (exenatide extended-release) in type-2 diabetes (T2D), including data on their use alone and in combination with other diabetes therapies. Highlights also include data on the potential new use of Farxiga in type-1 diabetes (T1D) and the debut of pre-clinical and clinical data for MEDI0382, an oxyntomodulin-like peptide and potential new medicine. MEDI0382 has the potential to be a first-in-class therapy, and is the latest candidate to advance in the Company’s CVRM pipeline.

First-ever Study of Lilly’s Humulin® R U-500 Administered in an Insulin Pump Shows Improved A1C in People with Type 2 Diabetes

June 25, 2018

Eli Lilly and Company’s Humulin® R U-500 administered via an investigational insulin pump (Omnipod® U-500™ Insulin Management System)  provided greater A1C reduction with less daily insulin needed compared to multiple daily injections (MDI) in adults with type 2 diabetes on high dose insulin (201-600 units/day). Data from this phase 3 study were presented for the first time at ADA 2018 in Orlando. Humulin R U-500 is Lilly’s highly concentrated insulin formulation that is used to control high blood sugar in people with diabetes who are insulin-resistant and need daily doses of more than 200 units of insulin.

Top News from ADA 2018 last edit: 2018-07-09T20:22:50+00:00 da Luca

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