Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.
Interventions
DRUGNNC0662-0419
NNC0662-0419 will be administered subcutaneously.
DRUGSemaglutide
Semaglutide will be administered subcutaneously.
DRUGPlacebo
Placebo will be administered subcutaneously.
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 (sex at birth). * Age 18-75 years (both inclusive) at the time of signing the informed consent. * Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as assessed by central laboratory at screening. * Willingness to obtain a high weight loss (greater than \[\>\] 25% of weight at baseline).
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) (week 16) | From baseline (week 0) to week 16 | Measured as percentage-point (%-point). |
| Change in HbA1c (week 28) | From baseline (week 0) to week 28 | Measured as %-point. |
| Change in HbA1c (week 40) | From baseline (week 0) to week 40 | Measured as %-point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to (week 40) | Measured as percentage (%). |
| Change in body weight | From baseline (week 0) to (week 40) | Measured as kilogram (kg). |
| Change in HbA1c | From baseline (week 0) to (week 16, 28 and 40) | Measured as %-point. |
| Change in Fasting Plasma Glucose (FPG) | From baseline (week 0) to (week 16, 28 and 40) | Measured as millimoles per litre (mmol/L). |
| Change in Body Mass Index (BMI) | From baseline (week 0) to (week 40) | Measured in kilograms per square metre (kg/m\^2). |
| Change in waist circumference | From baseline (week 0) to (week 40) | Measured in centimetre (cm). |
| Change in high sensitivity C-Reactive Protein (hsCRP) | From baseline (week 0) to (week 40) | Measured as ratio to baseline. |
| Change in total cholesterol | From baseline (week 0) to (week 40) | Measured as ratio to baseline. |
| Change in High-Density Lipoprotein (HDL) cholesterol | From baseline (week 0) to (week 40) | Measured as ratio to baseline. |
| Change in Low-Density Lipoprotein (LDL) cholesterol | From baseline (week 0) to (week 40) | Measured as ratio to baseline. |
| Change in triglycerides | From baseline (week 0) to (week 40) | Measured as ratio to baseline. |
| Change in Urine Albumin Creatinine Ratio (UACR) | From baseline (week 0) to (week 16, 28 and 40) | Measured as ratio to baseline. |
| Change in estimated Glomerular Filtration Rate (eGFR) (creatinine cystatin C-based Chronic Kidney Disease-Epidemiology Collaboration [CKD-EPI] 2021) | From baseline (week 0) to (week 40) | Measured in millilitres per minute per 1.73 square metre (mL/min/1.73 m\^2). |
| Number of adverse events | From baseline (week 0) to (week 48) | Measured as number of events. |
Countries
Croatia, Hungary, Japan, Poland, Portugal, Slovakia, South Korea, Spain, Thailand, United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed