What side effects are associated with this type of intervention?

Common side effects of basal insulin analogs, such as insulin efsitora alfa, include hypoglycemia, weight gain, and injection site reactions like redness, swelling, or pain. Other potential side effects can include allergic reactions, lipodystrophy, and, in rare cases, severe allergic responses.

What prior FDA approvals exist?

The FDA has approved several basal insulin analogs for the treatment of Type 2 Diabetes. Notable examples include insulin glargine (Lantus), insulin detemir (Levemir), and insulin degludec (Tresiba). These long-acting insulins help regulate blood glucose levels by providing a steady insulin release. Additionally, the FDA has approved GLP-1 receptor agonists like liraglutide (Victoza) and extended-release exenatide (Bydureon), which are often used in combination with basal insulin to improve glycemic control. These treatments aim to manage blood sugar levels effectively and reduce the risk of diabetes-related complications.

What other types of research exist?

Promising novel alternatives to Insulin efsitora alfa for Type 2 Diabetes patients include: 1) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has shown significant improvements in glycemic control and weight loss. 2) Once-weekly Semaglutide, a GLP-1 receptor agonist, which has demonstrated superior glycemic control and weight management compared to other treatments. 3) SGLT2 inhibitors, such as Canagliflozin and Empagliflozin, which not only improve glycemic control but also offer cardiovascular and renal benefits.

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Insulin

Insulin Efsitora Alfa vs. Insulin Degludec for Type 2 Diabetes (QWINT-2 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

Have diagnosis of T2D according to the World Health Organization Criteria

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

Have a diagnosis of T1D, latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8 to 12, week 22 to week 26, week 48 to week 52

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new type of insulin (LY3209590) to see if it works better or is safer than an existing insulin (degludec) for adults with type 2 diabetes who are starting long-acting insulin for the first time. The new insulin helps manage blood sugar levels, similar to other insulins. Insulin degludec is a new-generation ultra-long-acting basal insulin developed by NovoNordisk.

Who is the study for?

Adults with Type 2 Diabetes starting basal insulin for the first time can join. They should have an HbA1c level between 7.0% - 10%, be on a stable diabetes medication for at least three months, and continue it during the trial. Excluded are those with recent bariatric surgery, certain blood disorders, severe hypoglycemia history, serious heart issues or weight fluctuations.

What is being tested?

The study is testing Insulin Efsitora Alfa (LY3209590) against Insulin Degludec in adults who haven't used basal insulin before to see which one works better and is safer. Participants will randomly receive either of the two insulins while continuing their current diabetes medications.

What are the potential side effects?

Potential side effects may include low blood sugar levels (hypoglycemia), allergic reactions at injection sites, weight changes, swelling in arms or legs, and possibly other unknown risks that come with new treatments.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Type 2 Diabetes.

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I have been on a stable diabetes medication for at least 3 months.

Exclusion Criteria

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

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

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I had weight loss surgery less than a year ago.

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I've been hospitalized for ketoacidosis or coma more than once in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8 to 12, week 22 to week 26, week 48 to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8 to 12, week 22 to week 26, week 48 to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 to 12, week 22 to week 26, week 48 to 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 Body Weight

Change from Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L)

Change from Baseline in Fasting Glucose

+11 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

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 DegludecActive Control1 Intervention

Participants will receive insulin degludec 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, like insulin efsitora alfa, provide a steady level of insulin throughout the day and night, helping to maintain stable blood glucose levels and reduce the risk of hyperglycemia in Type 2 Diabetes patients. Other treatments, such as GLP-1 receptor agonists and DPP-4 inhibitors, enhance insulin secretion, inhibit glucagon release, and prolong the action of incretin hormones. These mechanisms are crucial as they address insulin resistance and impaired insulin secretion, improving glycemic control and reducing complications associated with Type 2 Diabetes.

Clinical Implications of Cardiovascular Outcome Trials in Type 2 Diabetes: From DCCT to EMPA-REG.[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.