What side effects are associated with this type of intervention?

Common treatments for prediabetes, particularly GLP-1 receptor agonists like liraglutide, exenatide, and dulaglutide, are known to enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and promote satiety. The primary side effects of these treatments include gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Additionally, there is a potential risk of thyroid C cell tumors, particularly in patients with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia. Other rare but serious side effects include pancreatitis and potential pancreatic neoplasia.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of type 2 diabetes, which are also relevant for managing prediabetes due to their mechanisms of enhancing insulin secretion, inhibiting glucagon release, slowing gastric emptying, and promoting satiety. Notable drugs in this category include liraglutide, exenatide, dulaglutide, and semaglutide. These medications have shown efficacy in improving glycemic control and promoting weight loss, which are critical factors in the management of prediabetes.

What other types of research exist?

Promising novel alternatives to GLP-1 for prediabetes patients include Dipeptidyl Peptidase-4 (DPP-4) inhibitors, which enhance insulin release and inhibit glucagon release. Additionally, combination therapies such as phentermine-topiramate and bupropion-naltrexone, which promote satiety and weight loss, are emerging as effective options. Advances in personalized medicine, including pharmacogenetics, may also guide individualized treatment approaches.

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Glucagon-like peptide-1 (GLP-1) receptor agonist

Semaglutide for Prediabetes

Phase 4

Recruiting

Led By Absalon D Gutierrez, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

High risk for progression to diabetes: Obesity (BMI ≥ 30 kg/m2) and/or metabolically unhealthy status (elevated blood pressure, elevated triglycerides, low HDL cholesterol, and elevated fasting glucose)

Be older than 18 years old

Must not have

History of active malignancy

Family history of medullary thyroid cancer or MEN2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial uses a hormone to study its effects on blood sugar, weight, heart health, and kidney function in Mexican-Americans with prediabetes. The goal is to understand how genetic differences affect individual responses to the hormone and to create personalized treatments for diabetes and related conditions. The hormone has been studied for many years, showing benefits in blood sugar control, weight loss, and heart health.

Who is the study for?

This trial is for Mexican-Americans with prediabetes, particularly those at high risk of developing diabetes due to obesity or metabolic issues. Participants must be adults with specific blood and kidney function levels, and women who can have children should use birth control during the study. People taking certain diabetes medications or with a history of serious diseases like pancreatitis, thyroid cancer, or active malignancy cannot join.

What is being tested?

The trial is studying how people respond to Semaglutide—a drug that mimics a hormone important for lowering blood sugar and aiding weight loss—by looking at their genes and gene activity. The goal is to understand why different people react differently to this treatment.

What are the potential side effects?

Semaglutide may cause digestive problems (like nausea or diarrhea), potential allergic reactions, increased heart rate, possible inflammation of the pancreas (pancreatitis), changes in vision if you have diabetic retinopathy, and low blood sugar when used with other diabetes medicines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at high risk for diabetes due to obesity or unhealthy metabolism.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cancer.

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My family has a history of medullary thyroid cancer or MEN2.

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I have a serious heart, liver, pancreas, or kidney disease.

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I was hospitalized for COVID-19 in the last 3 months.

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I have been diagnosed with diabetes.

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I have recently used diabetes or steroid medications.

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I have a history of pancreatitis, medullary thyroid cancer, or MEN 2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disposition Index

GLP-1-Induced Potentiation

Gene expression changes for minor variants of eQTLs for CHST3

+14 more

Secondary study objectives

Change in hemoglobin A1C

Creation of eQTL-based disease prediction models

Mean change in C-peptide Area Under the Curve (AUC)

+3 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848

21%

Nausea

12%

Decreased Appetite

100%

80%

60%

40%

20%

Study treatment Arm

Overall Study

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SemaglutideExperimental Treatment1 Intervention

Semaglutide 0.25 mg subcutaneously weekly for 4 weeks, followed by semaglutide 0.5 mg subcutaneously weekly for 8 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

2021

Completed Phase 4

~5160

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glucagon-like peptide-1 (GLP-1) receptor agonists are a common treatment for prediabetes due to their multifaceted mechanisms of action. They enhance insulin secretion in response to meals, which helps lower blood glucose levels. Additionally, they inhibit the release of glucagon, a hormone that raises blood glucose levels, thereby providing a dual approach to glucose regulation. GLP-1 receptor agonists also slow gastric emptying, which leads to a more gradual absorption of nutrients and helps prevent spikes in blood sugar. Furthermore, they promote satiety, reducing overall food intake and aiding in weight loss. These combined effects are crucial for prediabetes patients as they help manage blood glucose levels and reduce the risk of progression to type 2 diabetes.