This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes. The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies. Participants will either get: Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine). NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance. Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo. Participant must inject the study medicines themself into the stomach, thigh, or upper arm. The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study. Women can only take part in the study if they are not able to become pregnant
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.
A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.
A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Pinnacle Research Group LLC
Anniston, Alabama, United States
Synexus Clinical Research
Glendale, Arizona, United States
University of Arizona/Banner Health
Phoenix, Arizona, United States
American Clinical Trials
Buena Park, California, United States
San Fernando Valley Hlth Inst, LLC
Canoga Park, California, United States
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) to week 34 in FPG is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Change From Baseline in Body Weight (Kilogram [kg])
Change from baseline (week 0) to week 34 in body weight is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Percent Change From Baseline in Body Weight
Percent change from baseline (week 0) to week 34 in body weight (measured in Kgs) is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Change From Baseline in Waist Circumference
Change from baseline (week 0) to week 34 in waist circumference is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Change From Baseline in Systolic Blood Pressure (SBP)
Change from baseline (week 0) to week 34 in systolic blood pressure is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Relative Change From Baseline in Total Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in total cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in HDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in LDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 34 in VLDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Relative Change From Baseline in Triglycerides - Ratio to Baseline
Change from baseline (week 0) to week 34 in triglycerides measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline
Change in baseline (week 0) to week 34 in free fatty acids measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline
Change from baseline (week 0) to week 34 in ApoB measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Change from baseline (week 0) to week 34 in hsCRP measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Time frame: Baseline (week 0), (week 34)
Number of Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP). All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on treatment period. On treatment period: the time period where all observed data for which subjects are considered exposed to randomised treatment.
Time frame: Baseline (week 0) to (week 39)
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