Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes

Launched by NOVO NORDISK A/S · May 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called CagriSema, which combines two existing medications, cagrilintide and semaglutide, to see how they affect insulin in people with Type 2 diabetes (T2D). The goal is to understand how these treatments work in the body to help manage diabetes. Participants in the trial may receive CagriSema, semaglutide, cagrilintide, or a placebo (a "dummy" medicine that doesn’t contain any active ingredients). The study will run for about 42 weeks, and all participants will also take their usual diabetes medication, metformin.

To join the study, participants need to be between 18 and 75 years old and have been diagnosed with Type 2 diabetes for at least six months. They should also be on a stable dose of metformin. The trial is open to both men and women, but pregnant or breastfeeding women cannot participate. Throughout the study, participants will be monitored to ensure their health is managed properly. This trial is important because it may lead to new options for people with Type 2 diabetes, helping them better control their blood sugar levels.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female.
• • Aged 18-75 years (both inclusive) at the time of signing informed consent.
• • Diagnosed with type 2 diabetes greater than or equal to (\>=) 180 days before screening.
• • Stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for 90 or more days before screening with or without one additional oral antidiabetic drug (OAD), except for the use of glucagon-like peptide-1 (GLP-1) receptor agonists, or sodium-glucose co-transporter-2 (SGLT-2) inhibitors in case of a high risk of cardiovascular disease (as judged by the investigator), or established cardiovascular disease, or chronic kidney disease (Glomerular Filtration Rate (eGFR) less than (\<) 60 milliliter per minute per 1.73 square meter \[ml/min/1.73 m\^2\]).
• • Glycated hemoglobin (HbA1c) at screening of 6.5-9.5 percent (48-80 millimoles per mole \[mmol/mol\]) (both inclusive) if on metformin only, or 6.0- 9.0 percent (42-75 mmol/mol) (both inclusive) if on metformin in combination with one other OAD. A minimum of 65% of randomised participants must have HbA1c \>= 7.0 % at screening.
• • Body Mass index (BMI) between 25.0 and 45.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
• Exclusion Criteria:
• • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
• • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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.
• • Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73 m\^2 at screening.
• • Treatment with any medication for the indication of T2D or weight management 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.