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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
CagriSema will be administered s.c. once weekly.
Number of treatment emergent adverse events (TEAEs)
Measured as count of events.
Time frame: From baseline (Week 0) to end of treatment (Week 16)
Number of TEAEs
Measured as count of events.
Time frame: From baseline (Week 0) to end of study (Week 22)
Number of TEAEs
Measured as count of events.
Time frame: From baseline (Week 0) to Week 8
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)
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)
Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Measured as count of episodes.
Time frame: From baseline (Week 0) to Week 8
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.
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Gilbert Center For Family Medicine
Gilbert, Arizona, United States
Ark Clinical Research
Fountain Valley, California, United States
Thrive Clinical Research Group
Glendora, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
Downtown LA Res Ctr. Inc.
Los Angeles, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Dream Team Clinical Research
Pomona, California, United States
Clinical Trials Research_Sacramento
Sacramento, California, United States
Linda Vista Health Care Ctr
San Diego, California, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
...and 30 more locations
Time frame: From baseline (Week 0) to Week 8
Number of participants who discontinued due to gastrointestinal (GI) adverse events (AEs)
Measured as count of participants.
Time frame: From baseline (Week 0) to end of treatment (Week 16)