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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of study (week 75)
Awards & highlights
REDEFINE 2 Trial Summary
This trial will study a new medicine to help people with type 2 diabetes and excess body weight to lose weight. Participants will be chosen at random to receive the medicine or a dummy. Women cannot take part if pregnant or planning to be.
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.Check my eligibility
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.See study design
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.
REDEFINE 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
REDEFINE 2 Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Achievement of greater than or equal to (≥) 5% weight reduction
Secondary outcome measures
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
+31 moreREDEFINE 2 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
Semaglutide
FDA approved
Cagrilintide
2023
Completed Phase 1
~150
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,520 Previous Clinical Trials
2,415,165 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
109 Previous Clinical Trials
139,312 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either male or female.I was diagnosed with type 2 diabetes more than 6 months ago.Your HbA1c level is between 7% and 10% as measured by the central laboratory at screening.I don't have unstable diabetic eye problems as checked by a recent eye exam.You weigh more than what is considered healthy for your height.I haven't had severe low blood sugar or unnoticed low blood sugar episodes in the last 6 months.I am managing my diabetes with up to 3 oral medications or lifestyle changes.My diabetes medication has been the same for the last 3 months.I am 18 years old or older.My kidney function is low, with an eGFR below 30.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: CagriSema
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05394519 — Phase 3
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