Anti-diabetic drugs

First half of 2021: Boehringer Ingelheim makes fundamental progress in research and development

Retrieved on: 
Tuesday, August 3, 2021

In July, Boehringer Ingelheim reported a breakthrough in the treatment of heart failure with empagliflozin (marketed as JARDIANCE).

Key Points: 
  • In July, Boehringer Ingelheim reported a breakthrough in the treatment of heart failure with empagliflozin (marketed as JARDIANCE).
  • Boehringer Ingelheim also made progress in the area of neuropsychiatric disorders, including two ongoing phase II trials.
  • Quantum computing holds enormous potential for pharmaceutical research and development, particularly for early research processes in which Boehringer Ingelheim has a high level of expertise.
  • Following a successful financial year 2020, Boehringer Ingelheim continued its positive trend in the first half of 2021.

BYDUREON BCise (exenatide extended-release) Approved in the US for the Treatment of Type 2 Diabetes in Pediatric Patients Ages 10 Years and Older

Retrieved on: 
Friday, July 23, 2021

This is the first completed trial of a once-weekly GLP-1 RA in a pediatric population with T2D.

Key Points: 
  • This is the first completed trial of a once-weekly GLP-1 RA in a pediatric population with T2D.
  • Safety and effectiveness of exenatide extended-release have not been established in pediatric patients less than 10 years of age.
  • If this occurs, patients should discontinue BYDUREON BCise and promptly seek medical advice
    Drug-induced, immune-mediated thrombocytopenia and associated bleeding has been reported with exenatide.
  • Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide.

Breakthrough results for empagliflozin confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction

Retrieved on: 
Tuesday, July 6, 2021

When added to the EMPEROR-Reduced trial results, these findings demonstrate empagliflozins efficacy in all forms of heart failure regardless of ejection fraction.

Key Points: 
  • When added to the EMPEROR-Reduced trial results, these findings demonstrate empagliflozins efficacy in all forms of heart failure regardless of ejection fraction.
  • HFpEF has long been the most challenging form of heart failure to treat, said Professor Stefan Anker, Heart Failure Cardiologist at Charit Berlin, Germany, and EMPEROR-Preserved Principal Investigator.
  • Building on previous results from the EMPA-REG-OUTCOME trial, and the EMPEROR-Reduced trial in heart failure with reduced ejection fraction, the EMPEROR-Preserved findings demonstrate that empagliflozin reduces cardiovascular death or hospitalization for heart failure and has the potential to transform the care of people living with heart failure.
  • With the earlier EMPEROR-Reduced trial results, we are confident in the potential of empagliflozin to positively impact the lives of adults across the full spectrum of heart failure.

Adocia Initiates BC LisPram Phase 1 Clinical Trial in Pump for People with Type 1 Diabetes

Retrieved on: 
Tuesday, June 29, 2021

So, we are very excited to study BC LisPram, which allows the use of only one pump to deliver both hormones, declared Dr. Ahmad Haidar.

Key Points: 
  • So, we are very excited to study BC LisPram, which allows the use of only one pump to deliver both hormones, declared Dr. Ahmad Haidar.
  • Adocia has developed two products, M1Pram in pen for Multiple Daily Injection, currently in Phase 2, and now BC LisPram for insulin pump delivery.
  • BioChaperone Lispro Pramlintide (BC LisPram) is a fixed combination of two approved hormones analogs, the insulin analog lispro and the amylin analog pramlintide.
  • Adocia recently added a preclinical program to its pipeline with a cell therapy initiative focused on development of a hydrogel scaffold for use in people with type 1 diabetes.

Adocia Initiates BC LisPram Phase 1 Clinical Trial in Pump for People with Type 1 Diabetes

Retrieved on: 
Tuesday, June 29, 2021

So, we are very excited to study BC LisPram, which allows the use of only one pump to deliver both hormones, declared Dr. Ahmad Haidar.

Key Points: 
  • So, we are very excited to study BC LisPram, which allows the use of only one pump to deliver both hormones, declared Dr. Ahmad Haidar.
  • Adocia has developed two products, M1Pram in pen for Multiple Daily Injection, currently in Phase 2, and now BC LisPram for insulin pump delivery.
  • BioChaperone Lispro Pramlintide (BC LisPram) is a fixed combination of two approved hormones analogs, the insulin analog lispro and the amylin analog pramlintide.
  • Adocia recently added a preclinical program to its pipeline with a cell therapy initiative focused on development of a hydrogel scaffold for use in people with type 1 diabetes.

Weekly Injection Of Glucose-Reducing Drug Offers Safe And Effective Way To Significantly Reduce Cardiorenal Events For People With Type 2 Diabetes

Retrieved on: 
Monday, June 28, 2021

The majority (98%) of adults with type 2 diabetes have at least one comorbid chronic condition, including cardiorenal conditions impacting the heart and kidney.

Key Points: 
  • The majority (98%) of adults with type 2 diabetes have at least one comorbid chronic condition, including cardiorenal conditions impacting the heart and kidney.
  • Earlier trials have shown that GLP-1 RA drugs based on human GLP-1 reduce cardiovascular and kidney outcomes.
  • The AMPLITUDE O trial was conducted in 28 countries and included more than 4,000 participants with type 2 diabetes.
  • Join the fight with us on Facebook (American Diabetes Association ), Twitter ( @AmDiabetesAssn ), and Instagram ( @AmDiabetesAssn ).

KidneyIntelX™ Enables Monitoring of SGLT2 Inhibitor Therapy Response and Corresponding Risk Reduction Over Time

Retrieved on: 
Monday, June 28, 2021

Until now, primary care physicians have not had an optimal way to assess risk for kidney disease progression in their type 2 diabetes patients.

Key Points: 
  • Until now, primary care physicians have not had an optimal way to assess risk for kidney disease progression in their type 2 diabetes patients.
  • KidneyIntelX provides early risk stratification which allows us to optimize and target patients in early stages of kidney disease with new medications such as SGLT2i, and moreover, these data support how KidneyIntelX can help monitor these patients and their response to treatment.
  • These results will be further evaluated through a growing body of real-world evidence and clinical effectiveness data driven by the KidneyIntelX multi-institutional study network in over 6,000 patients.
  • The ability of KidneyIntelX to assess SGLT2 inhibitor response and improvements in kidney health through repeat testing is a significant step towards broader utilization of new therapeutic agents to significantly reduce the risk of kidney failure.

Empagliflozin reduced the risk of cardiovascular events and hospitalization for heart failure compared to DPP-4 inhibitors in people with type 2 diabetes

Retrieved on: 
Monday, June 28, 2021

Empagliflozin was not associated with a risk of acute kidney injury - analyses showed a 51 percent RRR in acute kidney injury requiring dialysis.

Key Points: 
  • Empagliflozin was not associated with a risk of acute kidney injury - analyses showed a 51 percent RRR in acute kidney injury requiring dialysis.
  • There was a similar risk of lower limb amputation and bone fractures as with DPP-4 inhibitors.
  • In addition, there was an increased risk of diabetic ketoacidosis, which is consistent with empagliflozins known safety information.1
    The risk of hospitalization for heart failure is up to five times higher if you have type 2 diabetes.
  • 9 It is a widespread condition affecting over 60 million people worldwide and expected to increase as the population ages.

Dapagliflozin is Well Tolerated in Hospitalized COVID-19 Patients

Retrieved on: 
Sunday, June 27, 2021

Patients received dapagliflozin or placebo for 30 days in addition to the standard of care for COVID-19 in the participating hospital.

Key Points: 
  • Patients received dapagliflozin or placebo for 30 days in addition to the standard of care for COVID-19 in the participating hospital.
  • Numerically fewer patients treated with dapagliflozin experienced organ failure or death (11.2% versus 13.8% with placebo, respectively), although this difference was not statistically significant.
  • Dapagliflozin was well tolerated, with numerically fewer serious adverse events than placebo, and these findings were also consistent in patients with and without type 2 diabetes.
  • The authors state that future trials are needed to further evaluate possible effects of dapagliflozin on the risk of organ failure or death in patients hospitalized with COVID-19.

Phase III pivotal trial of once weekly exenatide in adolescents aged 10–17 shows benefit for the treatment of type 2 diabetes

Retrieved on: 
Friday, June 25, 2021

This Phase III trial is the first and only completed trial of a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) in adolescents aged 1017 with T2D.

Key Points: 
  • This Phase III trial is the first and only completed trial of a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) in adolescents aged 1017 with T2D.
  • James Ruggles, BYDUREON Medical Lead, said: Were greatly encouraged by these results in adolescents with type 2 diabetes.
  • We hope that, once approved, exenatide once weekly will serve as a much needed convenient treatment option for adolescent patients.
  • Consequently, once weekly injections of exenatide could fill that gap in treatment options for T2D patients in this age group.