Type 2 Diabetes (T2D)
Conditions
Brief summary
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.
Interventions
DRUGNNC0487-0111 subcutanous
NNC0487-0111 administered subcutanously (under the skin)
DRUGPlacebo (NNC0487-0111 subcutanous)
NNC0487-0111 placebo administered subcutanously (under the skin)
DRUGNNC0487-0111 oral
NNC0487-0111 administered orally (in the mouth)
DRUGPlacebo (NNC0487-0111 oral)
NNC0487-0111 placebo administered orally (in the mouth)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening. * Stable daily dose(s) greater or equal to 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitor. * HbA1c of 7.0-10.0 procent (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening. * Body mass index between greater or equal to 23.0 and below 50.0 kg/m\^2. * Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study, as judged by the investigator.
Exclusion criteria
* 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 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. * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | From baseline (week 0) to end of treatment (week 36) | percent point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to end of treatment (week 36) | percent |
| Change in body weight | From baseline (week 0) to end of treatment (week 36) | kg |
| Change in fasting plasma glucose (FPG) | From baseline (week 0) to end of treatment (week 36) | mmol/L |
| CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) | From baseline (week 0) to end of treatment (week 36) | percent points |
| Change in body mass index (BMI) | From baseline (week 0) to end of treatment (week 36) | kg/m\^2 |
| Change in waist circumference | From baseline (week 0) to end of treatment (week 36) | cm |
| Change in systolic blood pressure (SBP) | From baseline (week 0) to end of treatment (week 36) | mmHg |
| Change in average 24-hour systolic blood pressure (SBP) | From baseline (week 0) to end of treatment (week 36) | mmHg |
| Change in high sensitivity C-Reactive Protein (hsCRP) | From baseline (week 0) to end of treatment (week 36) | Ratio to baseline |
| Change in total cholesterol | From baseline (week 0) to end of treatment (week 36) | Ratio to baseline |
| Change in high-density lipoprotein (HDL) cholesterol | From baseline (week 0) to end of treatment (week 36) | Ratio to baseline |
| Change in low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to end of treatment (week 36) | Ratio to baseline |
| Change in triglycerides | From baseline (week 0) to end of treatment (week 36) | Ratio to baseline |
| Number of adverse events | From baseline (week 0) to end of study (week 40) | Count of events |
| Change in Urinary Albumin/Creatinine Ratio (UACR) | From baseline (week 0) to end of treatment (week 36) | Ratio to baseline |
| Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g) | At end of treatment (week 36) | Count of participant |
| Change in eGFR creatinine- and cystatin C based CKD-EPI | From baseline (week 0) to end of treatment (week 36) | mL/min/1.73 m\^2 |
Countries
Bulgaria, Croatia, Germany, Greece, Hungary, Japan, Poland, Romania, Slovakia, Spain, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed