The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
448
NNC0487-0111 administered subcutanously (under the skin)
NNC0487-0111 placebo administered subcutanously (under the skin)
NNC0487-0111 administered orally (in the mouth)
Change in HbA1c
percent point
Time frame: From baseline (week 0) to end of treatment (week 36)
Relative change in body weight
percent
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in body weight
kg
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in fasting plasma glucose (FPG)
mmol/L
Time frame: From baseline (week 0) to end of treatment (week 36)
CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)
percent points
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in body mass index (BMI)
kg/m\^2
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in waist circumference
cm
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in systolic blood pressure (SBP)
mmHg
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in average 24-hour systolic blood pressure (SBP)
mmHg
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NNC0487-0111 placebo administered orally (in the mouth)
Uni of Alabama at Birmingham
Birmingham, Alabama, United States
Velocity Clin Research LA
Los Angeles, California, United States
Southern Cal Clinical Research
Santa Ana, California, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
Fleming Island Ctr for Clin Res
Fleming Island, Florida, United States
Encore Medical Research LLC
Hollywood, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
Florida Inst For Clin Res
Orlando, Florida, United States
Florida Institute for Clinical research
Orlando, Florida, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
...and 127 more locations
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in high sensitivity C-Reactive Protein (hsCRP)
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in total cholesterol
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in high-density lipoprotein (HDL) cholesterol
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in low-density lipoprotein (LDL) cholesterol
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in triglycerides
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Number of adverse events
Count of events
Time frame: From baseline (week 0) to end of study (week 40)
Change in Urinary Albumin/Creatinine Ratio (UACR)
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g)
Count of participant
Time frame: At end of treatment (week 36)
Change in eGFR creatinine- and cystatin C based CKD-EPI
mL/min/1.73 m\^2
Time frame: From baseline (week 0) to end of treatment (week 36)