No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
210 (estimated)
Sponsor
Novo Nordisk A/S · Industry
Who this trial is looking for
This trial is looking for adults with type 2 diabetes who are currently stable on a specific diabetes injection. Participants will switch to a new treatment called CagriSema for about 6 months to see how well they tolerate it.
Are You a Good Fit for This Trial?
Must be takingSemaglutide
You may be able to join if
I am at least 18 years old.
I have been diagnosed with type 2 diabetes for more than 180 days.
I have been using semaglutide injections for at least 90 days.
I have not used any oral diabetes medications recently.
My hemoglobin A1c level is between 6.5% and 10.5%.
My body mass index (BMI) is at least 25.
You may not be able to join if
I am pregnant or breastfeeding.
I plan to become pregnant soon.
I have severe kidney problems.
I have uncontrolled eye issues related to diabetes.
I have lost more than 5% of my body weight recently.
I use a personal continuous glucose monitor.
I have taken diabetes or obesity medications other than those listed recently.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this clinical study is to look at the safety and tolerability of switching from semaglutide to CagriSema, for participants who have type 2 diabetes. All participants will get CagriSema, the treatment being tested. Participants will be in this clinical study for about 6 months.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion criteria:
* Male or female (sex assigned at birth, inclusive of all gender identities).
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus (T2DM) greater than or equal to (≥) 180 days before screening.
* Stable once-weekly dose ≥…
Inclusion criteria:
* Male or female (sex assigned at birth, inclusive of all gender identities).
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus (T2DM) greater than or equal to (≥) 180 days before screening.
* Stable once-weekly dose ≥ 90 days before screening of branded s.c. semaglutide. Branded semaglutide s.c. includes Ozempic and Wegovy. Participants on compounded semaglutide are ineligible.
* Not on treatment with oral antidiabetic drugs or on stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen at effective or maximum tolerated dose (MTD) as judged by the investigator: metformin and/or sodiumglucose co-transporter-2 (SGLT2) inhibitor.
* Glycated haemoglobin (HbA1c) 6.5-10.5 percentage (%) (48-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
* Body mass index (BMI) ≥ 25 kilograms per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
Exclusion criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method from screening.
* Renal impairment with estimated glomerular filtration rate (eGFR) less than (\<) 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* A self-reported change in body weight \> 5% within 90 days before screening irrespective of medical records.
* Use of personal continuous glucose monitoring (CGM) devices. Participants currently using personal CGM devices must discontinue use prior to screening and throughout study participation.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.