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CagriSema Dose 2 for Type 2 Diabetes (REIMAGINE 1 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 1 Trial Summary

This trial will investigate whether a new experimental medicine called CagriSema can help people with type 2 diabetes reduce their blood sugar and body weight. Participants will be randomly assigned to receive either C

Who is the study for?

This trial is for people with type 2 diabetes who manage their condition through diet and exercise. Participants will be involved in the study for about a year, receiving either the investigational medicine CagriSema or a placebo.Check my eligibility

What is being tested?

The study tests how well CagriSema, an experimental medication not yet available by prescription, lowers blood sugar and body weight compared to a placebo—a treatment with no active effect on the body.See study design

What are the potential side effects?

Potential side effects of CagriSema are not detailed here but may include those typical of diabetes medications such as nausea, low blood sugar levels (hypoglycemia), and digestive issues.

REIMAGINE 1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to end of treatment +7 weeks (week 47)

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 Diabetes Treatment Satisfaction Questionnaire (DTSQ) score

Change in Fasting Plasma Glucose (FPG)

Change in SF-36v2 score: Mental Component Summary score

+27 more

REIMAGINE 1 Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: CagriSema Dose 2Active Control2 Interventions

Participants will receive once-weekly subcutaneous (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 2Placebo Group1 Intervention

Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 2 for 40 weeks.

Group IV: Placebo Dose 1Placebo Group1 Intervention

Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 1 for 40 weeks.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,514 Previous Clinical Trials

2,414,888 Total Patients Enrolled

Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S

106 Previous Clinical Trials

139,646 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 process currently ongoing for this research study?

"According to information found on clinicaltrials.gov, recruitment for this study is currently closed. The trial was listed on 3/19/2024 and last modified on 3/15/2024. However, amidst the inactive status of this particular trial, there are a substantial number of 1464 alternative studies available for patient enrollment at present."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"This clinical trial is conducted at Valley Clinical Trials, Inc. in Northridge, Texas; Southern California Dermatology in Santa Ana, Florida; and Northeast Clinical Research of San Antonio in San Antonio, Massachusetts among 33 additional sites nationwide."

Answered by AI

What are the safety considerations related to Cagrisema Dose 1 in patients?

"Based on our evaluation, the safety rating of Cagrisema Dose 1 is categorized as a level 3. This classification stems from its Phase III trial status, indicating existing efficacy data and robust safety records."

Answered by AI