What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, such as basal insulin analogs (e.g., insulin glargine and insulin efsitora alfa), often have side effects including hypoglycemia (low blood sugar), weight gain, and injection site reactions. Other treatments like GLP-1 receptor agonists (e.g., dulaglutide) can cause gastrointestinal issues such as nausea, vomiting, and diarrhea. Long-term use of these medications generally requires monitoring for these side effects to manage and mitigate their impact on patients.

What prior FDA approvals exist?

The FDA has approved several basal insulin analogs for the treatment of Type 2 Diabetes, including insulin glargine and insulin detemir, which are long-acting insulins designed to provide a steady level of insulin over 24 hours. Additionally, GLP-1 receptor agonists such as liraglutide, exenatide, and dulaglutide have been approved for their efficacy in improving glycemic control and offering cardiovascular benefits. SGLT2 inhibitors like dapagliflozin have also been approved, providing an alternative mechanism for lowering blood glucose levels by promoting glucose excretion through the urine.

What other types of research exist?

Promising alternatives to Insulin efsitora alfa for Type 2 Diabetes patients include: 1) Exenatide-APT<subHSA</sub, which has a 4-fold longer plasma half-life and improved anti-hyperglycemic effects compared to exenatide. 2) Liraglutide, which has shown efficacy in combination with insulin. 3) Fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi), which has demonstrated improved glycemic control in patients inadequately controlled on basal insulin and oral antidiabetic drugs. 4) Linagliptin as an add-on to basal insulin, which has shown long-term efficacy and safety. 5) Tofogliflozin as an add-on to insulin, which has demonstrated long-term safety and efficacy.

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Insulin

Insulin Efsitora Alfa vs. Insulin Glargine for Type 2 Diabetes (QWINT-1 Trial)

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

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

Must have

Are insulin naive

Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study

Must not have

Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery

Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new insulin called insulin efsitora alfa in adults with type 2 diabetes who are new to insulin therapy. The goal is to see if it works well and is safe compared to another insulin called insulin glargine. The new insulin helps the body use blood sugar more effectively.

Who is the study for?

This trial is for adults with Type 2 Diabetes who are starting basal insulin therapy for the first time. They should have an HbA1c level between 7.0% to 10.0%, be on a stable diabetes medication regimen, and not have used insulin except briefly or for gestational diabetes. People with recent severe diabetes complications, certain heart conditions, other types of diabetes, or those who've had specific surgeries or significant weight changes recently cannot join.

What is being tested?

The study is testing the effectiveness and safety of a new weekly insulin called Insulin Efsitora Alfa (LY3209590) compared to daily Insulin Glargine in people newly starting on long-acting insulin treatments for Type 2 Diabetes.

What are the potential side effects?

Potential side effects may include low blood sugar levels (hypoglycemia), allergic reactions at the injection site, weight gain, swelling in arms and legs, and possible systemic allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have never used insulin.

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I have been on a stable diabetes medication for at least 3 months and can continue it during the study.

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I have been diagnosed with Type 2 Diabetes.

Exclusion Criteria

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

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I have not had severe heart failure or major heart-related issues in the last 3 months.

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My weight has changed by more than 5% in the last 3 months.

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I have been diagnosed with a type of diabetes that is not type 2.

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I have a blood disorder that affects my hemoglobin levels.

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I was hospitalized for ketoacidosis or coma more than once in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in Hemoglobin A1c (HbA1c)

Secondary study objectives

Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction

Change from Baseline in Fasting Glucose

Change from Baseline in HbA1c

+5 more

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Insulin Efsitora AlfaExperimental Treatment1 Intervention

Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly.

Group II: Insulin GlargineActive Control1 Intervention

Participants will receive insulin glargine SC once daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Insulin Efsitora Alfa

2022

Completed Phase 3

~4140

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

Basal insulin analogs, such as insulin efsitora alfa, work by providing a steady level of insulin to help control blood glucose levels throughout the day and night, mimicking the natural basal insulin secretion of the pancreas. This is particularly important for T2D patients who have insulin resistance or insufficient insulin production. GLP-1 receptor agonists enhance glucose-dependent insulin secretion, suppress glucagon release, and slow gastric emptying, which helps in reducing postprandial glucose spikes. SGLT2 inhibitors lower blood glucose by preventing glucose reabsorption in the kidneys, leading to its excretion in the urine. These mechanisms are vital for T2D patients as they address different aspects of glucose regulation, thereby improving overall glycemic control and reducing the risk of diabetes-related complications.

Impact on guidelines: The general practitioner point of view.[Significance of combination therapy with an insulin sensitizer and a DPP-4(dipeptidyl peptidase-4) inhibitor].Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design.