What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, particularly long-acting insulin analogs like insulin efsitora alfa, often have side effects such as hypoglycemia (low blood sugar), weight gain, and injection site reactions. Other treatments, such as GLP-1 receptor agonists (e.g., exenatide, liraglutide), may cause gastrointestinal symptoms like nausea and vomiting. Premixed insulin formulations can lead to minor hypoglycemia and weight gain. It is important to monitor blood glucose levels regularly and adjust dosages to minimize these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes, including long-acting insulin analogs like insulin glargine and insulin degludec, which help regulate blood glucose levels over an extended period. Additionally, GLP-1 receptor agonists such as liraglutide and extended-release exenatide have been approved for their efficacy in improving glycemic control. These treatments are often used in combination with other antidiabetic medications like metformin to achieve better outcomes. The approval of these drugs is based on their demonstrated ability to manage blood sugar levels effectively and their safety profiles in clinical trials.

What other types of research exist?

Promising alternatives to Insulin efsitora alfa for Type 2 Diabetes patients include: 1) Exenatide-APT<subHSA, which has a 4-fold longer plasma half-life and improved anti-hyperglycemic effects compared to exenatide. 2) The fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi), which has shown efficacy in patients inadequately controlled on basal insulin and oral antidiabetic drugs. 3) Liraglutide, a long-acting GLP-1 analog, which has demonstrated improved glycemic control and weight management in combination with insulin.

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Insulin

Insulin Efsitora Alfa for Type 2 Diabetes

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

once daily U100 or U300 of insulin glargine

once daily U100 or U200 of insulin degludec

Must not have

Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening

Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 22 to week 26

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new insulin drug called insulin efsitora alfa to see if it is safe and effective for people with Type 2 diabetes who are already using basal insulin. The study aims to help better control blood sugar levels over several months.

Who is the study for?

This trial is for adults with Type 2 diabetes who are already using basal insulin. They should be taking a stable dose of certain insulins, have a BMI of 45 kg/m² or less, and an HbA1c level between 6.5% - 10%. People with untreated cancer, recent bariatric surgery, severe liver disease (except NAFLD), pregnancy, Type 1 diabetes, significant weight changes in the last three months or specific heart conditions can't join.

What is being tested?

The study tests if Insulin Efsitora Alfa (LY3209590) is as safe and effective as Insulin Degludec in people with Type 2 diabetes currently treated with basal insulin. The trial includes screening, treatment for over a year and follows up to check safety after stopping the drug.

What are the potential side effects?

Potential side effects may include low blood sugar levels (hypoglycemia), allergic reactions at injection sites like redness or swelling, weight gain due to insulin use, and possibly other unknown risks associated with new drugs.

Eligibility Criteria

Inclusion Criteria

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

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I take U100 or U300 insulin glargine daily.

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I am taking U100 or U200 insulin degludec daily.

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I use insulin detemir or NPH insulin once or twice daily.

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I am not taking DPP-4 inhibitors for diabetes.

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I have Type 2 diabetes and am treated with basal insulin.

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I take between 10 and 110 units of basal insulin daily.

Exclusion Criteria

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

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I had weight loss surgery less than a year ago.

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I do not have liver disease, except for NAFLD.

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I have cancer that is currently active or hasn't been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 22 to week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 22 to week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 22 to week 26 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 Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)

Change from Baseline in Fasting Glucose

+7 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 be given insulin efsitora alfa subcutaneously (SC).

Group II: Insulin DegludecActive Control1 Intervention

Participants with be given insulin degludec SC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Insulin Efsitora Alfa

2022

Completed Phase 3

~4140

0 / 9Eligibility 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 long-acting insulin analogs, DPP-4 inhibitors, GLP-1 receptor agonists, and insulin sensitizers. Long-acting insulin analogs, such as insulin efsitora alfa, help regulate blood glucose levels by providing a steady release of insulin, which is crucial for maintaining glycemic control. DPP-4 inhibitors work by increasing the levels of incretin hormones, which stimulate insulin release and decrease glucagon levels. GLP-1 receptor agonists enhance insulin secretion, slow gastric emptying, and promote satiety, thereby improving blood glucose control. Insulin sensitizers like pioglitazone improve the body's response to insulin by reducing insulin resistance. These mechanisms are vital for Type 2 Diabetes patients as they target the underlying pathophysiology of the disease, helping to manage blood glucose levels effectively and reduce the risk of complications.

[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.DPP-4 inhibitors and GLP-1 analogues: for whom? Which place for incretins in the management of type 2 diabetic patients?