What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, particularly GLP-1 receptor agonists like semaglutide and liraglutide, often cause gastrointestinal side effects such as nausea, vomiting, and diarrhea. These medications can also lead to weight loss, which is generally beneficial but may be excessive for some patients. Insulin therapy, while effective for glycemic control, has been associated with an increased risk of cardiovascular events and weight gain. SGLT2 inhibitors, another class of diabetes medications, can cause urinary tract infections and an increased risk of amputations, particularly in patients with a history of peripheral artery disease.

What prior FDA approvals exist?

Several GLP-1 receptor agonists have been approved by the FDA for the treatment of Type 2 Diabetes, focusing on both blood sugar control and weight loss. Notable examples include exenatide, liraglutide, and semaglutide. Exenatide is available in both twice-daily and once-weekly formulations, while liraglutide is administered once daily. Semaglutide, which has shown greater efficacy, is administered once weekly. These drugs not only help in managing blood glucose levels but also contribute to weight loss, making them similar to the investigational drug CagriSema being studied for its combined effects on weight loss and blood sugar control.

What other types of research exist?

Promising alternatives to CagriSema for Type 2 Diabetes patients include GLP-1 receptor agonists like semaglutide and liraglutide, which have demonstrated significant efficacy in weight loss and glycemic control. Additionally, SGLT2 inhibitors such as canagliflozin and empagliflozin are notable for their cardiovascular benefits and glucose-lowering effects. These medications are supported by robust clinical trial data and are expected to remain at the forefront of diabetes management in 2024.

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Amylin Analog

CagriSema for Type 2 Diabetes and Obesity (REDEFINE 2 Trial)

Phase 3

Waitlist Available

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

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

Must have

Age above or equal to 18 years at the time of signing informed consent

Be older than 18 years old

Must not have

Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2, as measured by the central laboratory at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) to end of study (week 75)

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

Summary

This trial tests if the new medicine CagriSema can help people with excess body weight and type 2 diabetes lose weight. Participants will receive either CagriSema or another treatment. The study will last about a year and a half. Cagrilintide and semaglutide are both being investigated for weight management.

Who is the study for?

Adults with type 2 diabetes and a BMI of at least 27.0 kg/m^2 can join this study if they've been on stable oral diabetic medication for the past 90 days and have an HbA1c level between 7%-10%. They shouldn't be pregnant, breastfeeding, or planning pregnancy during the trial. People with severe kidney issues, recent serious hypoglycemia, or unstable diabetic eye problems cannot participate.

What is being tested?

The trial is testing CagriSema—a new medicine—against placebo versions to see how well it helps people with excess body weight and type 2 diabetes lose weight. Participants will receive either the real drug or a dummy version randomly over about one and a half years.

What are the potential side effects?

While specific side effects are not listed here, participants may experience reactions related to typical diabetes medications such as digestive discomfort, low blood sugar levels (hypoglycemia), potential injection site reactions, and possible allergic responses.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

My kidney function is low, with an eGFR below 30.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to end of study (week 75)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to end of study (week 75)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 75) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Achievement of greater than or equal to (≥) 5% weight reduction

Secondary study objectives

Achievement of HbA1c less than or equal to (≤) 6.5%

Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup

Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score

+30 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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: CagriSemaExperimental Treatment2 Interventions

Cagrilintide + semaglutide once weekly

Group II: PlaceboPlacebo Group2 Interventions

Placebo cagrilintide + semaglutide once weekly

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cagrilintide

2023

Completed Phase 1

~150

Semaglutide

FDA approved

0 / 2Eligibility 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

Incretin-based therapies, such as GLP-1 receptor agonists and DPP-4 inhibitors, are common treatments for Type 2 Diabetes. GLP-1 receptor agonists, like semaglutide, mimic the incretin hormone GLP-1, enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, which helps lower blood sugar levels and promotes weight loss. DPP-4 inhibitors prevent the breakdown of incretin hormones, thereby prolonging their action. These mechanisms are crucial for Type 2 Diabetes patients as they improve glycemic control and support weight management, addressing two key aspects of the disease.

Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.Overcoming obstacles in risk factor management in type 2 diabetes mellitus.