270 Participants Needed

CagriSema for Type 2 Diabetes

(REIMAGINE 3 Trial)

Recruiting at 55 trial locations
NN
Overseen ByNovo Nordisk
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novo Nordisk A/S
Must be taking: Basal insulin, Metformin
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

You can continue taking your current diabetes medications, like once-daily insulin and metformin, during the trial. However, if you are on other diabetes or obesity medications, you may need to stop those before joining.

What data supports the effectiveness of the drug CagriSema for treating type 2 diabetes?

Research shows that combining semaglutide with cagrilintide (CagriSema) has weight-loss benefits, which can help manage type 2 diabetes. Semaglutide alone has been shown to reduce body weight and insulin resistance, which are important factors in controlling diabetes.12345

Is CagriSema safe for humans?

Semaglutide, a component of CagriSema, has been studied for type 2 diabetes and obesity, showing common gastrointestinal side effects and rare cases of pancreatitis (inflammation of the pancreas), diabetic retinopathy (eye damage), and severe allergic reactions. These studies suggest it is generally safe but can have side effects.45678

What makes the drug CagriSema unique for treating type 2 diabetes?

CagriSema combines semaglutide, a glucagon-like peptide-1 analog that helps with weight loss and insulin resistance, with cagrilintide, potentially enhancing its effects. This combination may offer improved blood sugar control and weight management compared to existing treatments.29101112

What is the purpose of this trial?

This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.

Research Team

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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.

Inclusion Criteria

I am either male or female.
Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening
I was diagnosed with type 2 diabetes more than 6 months ago.
See 2 more

Exclusion Criteria

I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.
My kidney function is severely impaired, with an eGFR below 30.
I haven't taken diabetes or obesity drugs not listed in the criteria in the last 90 days.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-weekly subcutaneous injections of CagriSema or placebo for up to 40 weeks, with dose escalation periods for active comparators

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

Treatment Details

Interventions

  • Cagrilintide
  • Placebo
  • Semaglutide
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Findings from Research

In a 32-week trial with 92 participants, the combination of semaglutide and cagrilintide (CagriSema) led to a significant reduction in HbA1c levels compared to cagrilintide alone, indicating improved glycemic control in individuals with type 2 diabetes.
CagriSema also resulted in greater weight loss compared to both semaglutide and cagrilintide, demonstrating its potential as an effective treatment option for managing weight and blood sugar levels in this population.
Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial.Frias, JP., Deenadayalan, S., Erichsen, L., et al.[2023]
In a post hoc analysis of the SUSTAIN 1-3 trials involving 2432 participants with type 2 diabetes, semaglutide significantly reduced body weight (BW) by 3.7 to 6.1 kg compared to comparators, which only saw reductions of 1.0 to 1.9 kg.
The improvement in insulin resistance (IR) was primarily linked to weight loss, with 70% to 80% of the IR reduction from semaglutide 0.5 mg and 34% to 94% from semaglutide 1.0 mg being mediated by the decrease in BW.
Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide.Fonseca, VA., Capehorn, MS., Garg, SK., et al.[2023]
Oral semaglutide significantly reduces HbA1c levels and body weight in patients with type 2 diabetes, showing greater efficacy than placebo and other antidiabetic agents in a review of 11 randomized controlled trials involving 9890 patients.
While oral semaglutide is effective in managing blood glucose and weight, it is associated with increased gastrointestinal side effects like nausea and vomiting, although it has a favorable safety profile regarding severe hypoglycemia and cardiovascular events.
Oral semaglutide for type 2 diabetes: A systematic review and meta-analysis.Avgerinos, I., Michailidis, T., Liakos, A., et al.[2021]

References

Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. [2023]
Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. [2023]
Oral semaglutide for type 2 diabetes: A systematic review and meta-analysis. [2021]
Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial. [2022]
Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. [2022]
Efficacy and safety of oral semaglutide in type 2 diabetes mellitus: A systematic review and meta-analysis. [2023]
Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. [2022]
Semaglutide: a new drug for the treatment of obesity. [2023]
Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. [2022]
Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]
Semaglutide and Diabetic Retinopathy Risk in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. [2022]
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