Reviewed by Michael Gill, B. Sc.
Image of Loma Linda University Cancer Center in Loma Linda, United States.
Phase-Based Progress Estimates
1
Effectiveness
1
Safety

Evexomostatfor Malignant Neoplasms

18+
All Sexes
The PIK3CA gene is frequently mutated in breast cancer, leading to disease aggressiveness and patient mortality. Alpelisib, a small molecule that inhibits the activity of the PIK3CA gene product PI3Kα, has demonstrated clinical benefit in cancer patients with this gene mutation. However, hyperglycemia, an on-target toxicity associated with alpelisib that leads to hyperinsulinemia, limits the drug's clinical efficacy and induces high grade hyperglycemia in patients with baseline metabolic dysfunction, insulin resistance and/or elevated HbA1c. Restoring insulin sensitivity and reduction in circulating concentrations of insulin have been reported to improve the activity of alpelisib. Evexomostat (SDX-7320) is a polymer-conjugate of a novel small molecule methionine aminopeptidase 2 (MetAP2) inhibitor that has demonstrated the ability to reduce alpelisib-induced hyperglycemia in multiple animal experiments and has demonstrated synergistic anti-tumor activity independent of changes in glucose or insulin. Evexomostat was well tolerated in a Phase 1 safety study in late-stage cancer patients and showed improvements in insulin resistance for patients that presented with baseline elevated insulin. Overall, the most common treatment-emergent adverse events with evexomostat (TEAEs) were fatigue (44%), decreased appetite (38%), constipation and nausea (each 28%), and diarrhea (22%). All other TEAEs occurred at an incidence <20%. The purpose of this study is to characterize the safety of the triplet drug combination (alpelisib, fulvestrant plus evexomostat), to test whether evexomostat, when given in combination with alpelisib and fulvestrant will reduce the number and severity of hyperglycemic events and/or reduce the number of anti-diabetic medications needed to control the hyperglycemia for patients deemed at risk for alpelisib-induced hyperglycemia (baseline elevated HbA1c or well-controlled type 2 diabetes), and to assess preliminary anti-tumor efficacy and changes in key biomarkers and quality of life in this patient population.
Phase 1 & 2
Recruiting
Loma Linda University Cancer Center (+3 Sites)Neal Salomon, MDSynDevRx, Inc.
25 Insulin Clinical Trials Near Me
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Most Recent Insulin Clinical Trials

What Are Insulin Clinical Trials?

Insulin is a hormone produced by the pancreas which helps regulate glucose in the bloodstream. Certain conditions, such as diabetes or insulin resistance, can cause the body to lack insulin or be unable to use it properly.

Insulin clinical trials are research studies that test new insulin treatments in people with diabetes or insulin resistance. They can help by providing unique and innovative treatments that may be more effective than existing ones. They can also help to improve the quality of life for people with diabetes by testing new ways to manage the condition.

There are many different types of insulin clinical trials, and some look for insulin effects on the body. For example, this study looks at insulin versus insulin for gestational diabetes. Another pilot study examined insulin sensitivity in healthy individuals to see its effects on sleep and meal time.

Why is Insulin Studied in Clinical Trials?

Insulin is a hormone that helps the body to use glucose (sugar) for energy. People with diabetes either do not produce enough insulin, or their bodies cannot use insulin properly. Other people have insulin resistance or imbalances that can cause high blood sugar levels.

High blood sugar levels can lead to serious health problems like heart disease, stroke, kidney disease, and blindness. Insulin can help to control blood sugar levels and prevent these complications.

In some cases, insulin therapy may be used with other diabetes treatments, such as lifestyle changes or medications. These studies can provide insight into alternative lifestyle changes that can positively impact one's life without needing medication. An excellent example is this study that found that a high protein diet effectively improves insulin resistance and glycemic variability.

How Does Insulin Treatment Work?

Insulin therapy works by replacing the insulin the body is not producing or by helping the body use insulin more effectively. Insulin therapy can be given in different ways, depending on the type of insulin used.

Some types of insulin are taken as injections under the skin, while others are inhaled through the nose. Insulin therapy can also be given through an insulin pump, which continuously delivers insulin through a small tube inserted under the skin. Other insulin studies may change participants' diet, exercise, or lifestyle habits.

Currently, the CDC approves the following insulin types:

  • Rapid Acting
  • Rapid-Acting Inhaled
  • Regular/Short Acting
  • Intermediate Acting
  • Long Acting
  • Ulta-Long Acting
  • Premixed

Clinical studies can help determine which type is helpful for certain participants. Additionally, researchers will be able to find new and improved methods to provide insulin to patients if necessary.

What Are Some Breakthrough Clinical Trials Involving Insulin?

There are many insulin clinical trials taking place all over the world. Here are a few of the most promising ones:

A new type of insulin that can be inhaled through the nose is being studied in a clinical trial. The insulin, known as IN-105, is being developed by insulin manufacturer Novo Nordisk.

Another clinical trial tests a new type of insulin pump that can be worn on the body for up to two weeks at a time. The insulin pump, known as the t:slim X2 insulin pump, is made by insulin manufacturer Tandem Diabetes Care.

Who Are The Key Opinion Leaders On Insulin Clinical Trial Research?

Dr. Anne L. Peters, from the University of Southern California, is the Professor of Medicine at Keck School of Medicine and the Director of the USC Clinical Diabetes Programs. Her research focuses on conducting clinical trials on diagnosing and treating diabetes.

Dr. Robert Gabbay, from the Joslin Diabetes Center is Chief Medical Officer and Senior Vice President at Joslin Diabetes Center. He is also an Associate Professor at Harvard Medical School. His research focuses on improving delivery models of diabetes.

Dr. Steven V. Edelman, from the University of California, San Diego, is a Professor of Medicine and Endocrinologist. His research focuses on diabetes treatment, research, and patient advocacy.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: November 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

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