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There’s An Easier Way to Take Insulin, But It Hasn’t Been Tested on People Yet

AuroBlog - Aurous Healthcare Clinical Trials blog

The most effective way for people with diabetes to deliver insulin is also incredibly intrusive. Millions around the world must inject the crucial hormone underneath their skin several times a day to keep their glucose levels in balance.

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Julio Rosenstock, MD, FACE, Lead Author Published in OUP Endocrine Reviews Article

Velocity Clinical Research

Reviewing data from Phase 2 clinical trials for basal insulins icodec and efsitora, as well as the Phase 3 icodec program, the article indicates that once-weekly insulins provide comparable glycemic control to once-daily analogues, with a similar risk of hypoglycemia.

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Velocity Investigators Active at the American Diabetes Association (ADA) 83rd Scientific Sessions

Velocity Clinical Research

Rosenstock is the lead investigator for Novo Nordisk’s ONWARDS 1 program exploring the first investigational once-weekly insulin. “In In ONWARDS 1, insulin icodec allowed people to spend significantly more Time in Range, with comparable Time below Range vs. once-daily basal insulin glargine U100,” said Dr. Rosenstock. “A

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3 Reasons Why Linguistic Validation is Critical to Patient Diversity in Clinical Trials

XTalks

Multiple studies have confirmed that conducting clinical trials with a diverse range of ethnicities, genders, ages, and lifestyles is essential, since these factors can impact a treatment’s effectiveness among different groups. Despite this, ethnic minorities are underrepresented in clinical trials.

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Diamyd Diabetes Vaccine Study gets Green Light to Resume by the FDA

XTalks

In September 2021, the US Food and Drug Administration (FDA) issued a partial US clinical hold on the phase III DIAGNODE-3 clinical trial of the drug. ” The trial DIAGNODE-3 is approved and currently recruiting patients in eight countries in Europe. . The US Clinical Hold on the Diamyd Trial is Lifted, Now What?

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Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

XTalks

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Verifying the biomarker’s clinical validity for use as a surrogate endpoint in rare disease research is another hurdle which is generally a longer-term goal.

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Decline of novel drug approvals means less business for cutting-edge CMOs

Pharmaceutical Technology

The FDA even suggested that the company should conduct a multiregional clinical trial, as the drug’s pivotal trial was conducted only in China, where it is currently marketed for multiple oncology indications. The drug increases insulin synthesis and release. months longer on the treatment.

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