Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema
ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 m²) 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.
Trial design
Design model
Parallel
Treatments tested in this trial
CagriSema
DrugCagriSema will be administered s.c. once weekly.
Treatment groups
210 Participants
are divided into 3 treatment groupsGroup A: CagriSema dose 1Experimental treatment 1 intervention
Group B: CagriSema dose 2Experimental treatment 1 intervention
Group C: CagriSema dose 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of treatment emergent adverse events (TEAEs)
Measured as count of events.
Time frame
From baseline (Week 0) to end of treatment (Week 16)Secondary outcomes
1
Number of TEAEs
Measured as count of events.
Time frame
From baseline (Week 0) to end of study (Week 22)2
Number of TEAEs
Measured as count of events.
Time frame
From baseline (Week 0) to Week 83
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per liter [mmol/L] (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose [BG] meter)
Measured as count of episodes.
Time frame
From baseline (Week 0) to end of study (Week 22)4
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Measured as count of episodes.
Time frame
From baseline (Week 0) to end of study (Week 22)Sponsors and contacts
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Source ClinicalTrials.gov