What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include statins, ezetimibe, and PCSK9 inhibitors. Statins are associated with an increased incidence of new-onset diabetes and negative impacts on glucose metabolism. Ezetimibe has a relatively safe profile but lacks extensive evidence for its use in older adults. PCSK9 inhibitors, such as inclisiran, have been shown to effectively lower LDL-C levels with a safety profile comparable to placebo, though they may still leave LDL-C levels above the target goal. Additionally, GLP-1 receptor agonists, another class of diabetes treatments, have been linked to gastrointestinal issues, pancreatitis, and potential pancreatic cancer risks.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes, including dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, which has shown benefits in glycemic control and reducing adverse kidney outcomes. Additionally, glucagon-like peptide-1 (GLP-1) receptor agonists like dulaglutide and lixisenatide have been approved for their efficacy in improving glycemic control. While inclisiran sodium, a PCSK9 inhibitor, is primarily studied for cardiovascular risk reduction, it is not directly related to diabetes treatment but rather to lipid management in high cardiovascular risk patients.

What other types of research exist?

Promising alternatives to Inclisiran Sodium for Type 2 Diabetes patients in 2024 include Sodium-glucose co-transporter-2 (SGLT-2) inhibitors such as empagliflozin, dapagliflozin, and ipragliflozin, as well as dipeptidyl peptidase-4 (DPP-4) inhibitors like sitagliptin. Additionally, glucagon-like peptide-1 (GLP-1) receptor agonists are also considered effective options.

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RNA-based Therapeutic

Inclisiran for Cardiovascular Disease Prevention

Q: What is the mechanism of action of this treatment?

Common treatments for Type 2 Diabetes include SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors. SGLT2 inhibitors work by preventing glucose reabsorption in the kidneys, leading to increased glucose excretion and improved glycemic control. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps regulate blood sugar levels and promotes weight loss. DPP-4 inhibitors prolong the action of incretin hormones, thereby increasing insulin release and decreasing glucagon levels. These mechanisms are crucial for T2D patients as they not only improve blood sugar control but also offer cardiovascular benefits, which is particularly important given the high cardiovascular risk associated with diabetes. While Inclisiran Sodium (a PCSK9 inhibitor) is primarily used to lower LDL cholesterol and reduce cardiovascular events, its inclusion in diabetes management highlights the importance of comprehensive cardiovascular risk reduction in T2D patients.

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Participants at an increased risk for a first MACE (i.e., no prior major ASCVD event)

Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors

Must not have

History of major ASCVD event

Timeline

Screening 1 day

Treatment Varies

Follow Up time to the first occurrence of 4p-mace (up to approximately 75 months)

Awards & highlights

Pivotal Trial

Summary

This trial tests whether inclisiran injections can prevent serious heart problems in high-risk adults who haven't had a major heart event yet by lowering their cholesterol levels. Inclisiran is a long-acting treatment that significantly lowers cholesterol.

Who is the study for?

This trial is for adults aged 40-80 with high cholesterol and at increased risk of a first major cardiovascular event, but who haven't had one before. They should have an intermediate 10-year heart disease risk score with additional risk factors. Pregnant women, nursing mothers, or those in another study can't participate.

What is being tested?

The trial tests if Inclisiran sodium (a drug given by injection) can prevent serious heart-related events when administered initially, after three months, and then every six months compared to a placebo. The goal is to see if it reduces the occurrence of events like heart attacks or strokes.

What are the potential side effects?

While specific side effects are not listed here, Inclisiran may cause reactions at the injection site, allergic responses, liver enzyme changes, muscle pain or weakness among others based on its mechanism of action.

Eligibility Criteria

Inclusion Criteria

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

Select...

You have a higher risk of experiencing a first major cardiovascular event and have not had one before.

Select...

My heart disease risk for the next 10 years is between 7.5% and 20%, and I have at least two risk factors.

Select...

I am between 40 and 80 years old.

Exclusion Criteria

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

Select...

I have had a major heart or blood vessel event.

Timeline

Screening ~ 1 day1 visit

Treatment ~ Varies

Follow Up ~ time to the first occurrence of 4p-mace (up to approximately 75 months)

Screening ~ 1 day

Treatment ~ Varies

Follow Up ~time to the first occurrence of 4p-mace (up to approximately 75 months)

This trial's timeline: 1 day for screening, Varies for treatment, and time to the first occurrence of 4p-mace (up to approximately 75 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time to the first occurrence of 4P-MACE

Secondary study objectives

Time to occurrence of Cardiovascular death

Time to occurrence of death due to any reason

Time to the first occurrence of 3P-MACE

+2 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Inclisiran Sodium 300mgExperimental Treatment1 Intervention

Inclisiran sodium 300 mg in 1.5 mL Solution for injection (subcutaneous) in pre-filled syringe. Randomized in a 1:1 ratio with matching placebo

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran.

0 / 5Eligibility 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

Common treatments for Type 2 Diabetes include SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors. SGLT2 inhibitors work by preventing glucose reabsorption in the kidneys, leading to increased glucose excretion and improved glycemic control. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps regulate blood sugar levels and promotes weight loss. DPP-4 inhibitors prolong the action of incretin hormones, thereby increasing insulin release and decreasing glucagon levels. These mechanisms are crucial for T2D patients as they not only improve blood sugar control but also offer cardiovascular benefits, which is particularly important given the high cardiovascular risk associated with diabetes. While Inclisiran Sodium (a PCSK9 inhibitor) is primarily used to lower LDL cholesterol and reduce cardiovascular events, its inclusion in diabetes management highlights the importance of comprehensive cardiovascular risk reduction in T2D patients.

Effect of dapagliflozin on diabetic patients with cardiovascular disease via MAPK signalling pathway.Cardiovascular Safety and Benefits of Noninsulin Antihyperglycemic Drugs for the Treatment of Type 2 Diabetes Mellitus: Part 2.The EMPA-REG outcome study: critical appraisal and potential clinical implications.