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Glucagon-like Peptide-1 Receptor Agonist

CagriSema Dose 2 for Type 2 Diabetes (REIMAGINE 3 Trial)

Phase 3
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of treatment +7 weeks (week 47)
Awards & highlights

REIMAGINE 3 Trial Summary

"This trial will test a new medicine called CagriSema in people with type 2 diabetes to see if it can help lower their blood sugar and body weight. Participants will either receive Cag

Who is the study for?
This trial is for people with type 2 diabetes who are already taking once-daily basal insulin, with or without metformin. Participants should not be on any other diabetic medications and must have a stable dose of insulin for at least 90 days prior to the start of the study.Check my eligibility
What is being tested?
The study tests CagriSema, a new medication, against a placebo (a dummy medicine) in lowering blood sugar and body weight in type 2 diabetics. Patients will receive either CagriSema or placebo randomly while continuing their current diabetes treatment.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea or diarrhea, possible allergic reactions, changes in appetite, low blood sugar levels (hypoglycemia), and injection site reactions.

REIMAGINE 3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of treatment +7 weeks (week 47)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of treatment +7 weeks (week 47) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Glycated Haemoglobin (HbA1c)
Secondary outcome measures
Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score
Change in Diastolic Blood Pressure (DBP)
+28 more

REIMAGINE 3 Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: CagriSema Dose 2Active Control2 Interventions
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.
Group II: CagriSema Dose 1Active Control2 Interventions
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.
Group III: Placebo Dose 1Placebo Group1 Intervention
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 40 weeks.
Group IV: Placebo Dose 2Placebo Group1 Intervention
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 40 weeks

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,798 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
139,556 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical study currently ongoing?

"According to data from clinicaltrials.gov, the current trial is not actively seeking new participants. Initially posted on March 26th, 2024 and last modified on March 15th, 2024, this study has concluded patient recruitment. Nonetheless, there are currently 1465 alternative trials available for enrollment."

Answered by AI

What are the potential risks associated with administering CagriSema Dose 2 to patients?

"Our team at Power has rated the safety of CagriSema Dose 2 as a 3 on the scale due to its Phase 3 status, indicating existing efficacy data and robust safety information from multiple assessments."

Answered by AI

In how many medical facilities is this trial currently being conducted?

"At present, there are 47 active recruitment sites for this trial. These include locations in Tokyo, Nis, and Northridge among a total of 47 diverse sites. Opting for the nearest site is advisable to reduce travel obligations upon enrollment."

Answered by AI

Who else is applying?

What site did they apply to?
Bioclinical Research Alliance
Synergy Groups Medical
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin
2024. "A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06323161.
All > Anaheim > Greensboro
~180 spots leftby Sep 2025
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