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March 5, 2021updated 12 Jul 2022 11:22am

Lilly’s tirzepatide leads to body weight reductions in type 2 diabetes trial

Eli Lilly and Company has reported that results from the SURPASS-2 clinical trial of tirzepatide showed superior A1C and body weight reductions from baseline in adults with type 2 diabetes.

Eli Lilly and Company has reported that results from the SURPASS-2 clinical trial of tirzepatide showed superior A1C and body weight reductions from baseline in adults with type 2 diabetes.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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A novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist, tirzepatide combines the actions of both incretins into a single molecule.

The multi-centre, randomised, parallel, open-label trial analysed the efficacy and safety of tirzepatide as compared with semaglutide in adults with type 2 diabetes inadequately controlled with ≥1500 mg/day metformin alone.

Semaglutide is a GLP-1 receptor agonist for treating type 2 diabetes.

The trial enrolled 1,879 subjects in the US, UK, Argentina, Australia, Brazil, Canada, Israel and Mexico. They were randomised in a 1:1:1:1 ratio to receive either a 5mg, 10mg, or 15mg dose of tirzepatide or a 1mg dose of semaglutide.

Data showed that tirzepatide led to superior A1C and body weight reductions from baseline in all three tested doses versus semaglutide in the participants.

The highest dose of tirzepatide reduced A1C by 2.46% and body weight by 12.4kg, while the lowest dose reduced A1C by 2.09% and body weight by 7.8kg as against semaglutide at 1.86% and 6.2kg.

Furthermore, an A1C of less than 5.7% was achieved by 51% in tirzepatide 15mg arm versus 20% in semaglutide arm.

The overall safety profile of tirzepatide was similar to previously reported ones with the most commonly reported adverse events were gastrointestinal-related.

Lilly Diabetes president Mike Mason said: “Nearly nine in ten people with type 2 diabetes in the US are overweight or have obesity, and we are committed to providing solutions that not only lead to meaningful A1C reductions but also significant weight loss to help meet their needs.

“These striking head-to-head results surpassed our expectations, supporting our belief in the value of all three doses of tirzepatide as potential new treatment options for people living with type 2 diabetes.”

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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