A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
Purpose
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.
Condition
- Type 2 Diabetes (T2D)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo subcutaneous |
Placebo for subcutaneous treatment |
|
|
Experimental NNC0487-0111 subcutaneous dose 1 |
NNC0487-0111 subcutaneous dose 1 treatment |
|
|
Experimental NNC0487-0111 subcutaneous dose 2 |
NNC0487-0111 subcutaneous dose 2 treatment |
|
|
Experimental NNC0487-0111 subcutaneous dose 3 |
NNC0487-0111 subcutaneous dose 3 treatment |
|
|
Experimental NNC0487-0111 subcutaneous dose 4 |
NNC0487-0111 subcutaneous dose 4 treatment |
|
|
Experimental NNC0487-0111 subcutaneous dose 5 |
NNC0487-0111 subcutaneous dose 5 treatment |
|
|
Experimental NNC0487-0111 subcutaneous dose 6 |
NNC0487-0111 subcutaneous dose 6 treatment |
|
|
Placebo Comparator Placebo oral |
Placebo for oral treatment |
|
|
Experimental NNC0487-0111 oral dose 1 |
NNC0487-0111 oral dose 1 treatment |
|
|
Experimental NNC0487-0111 oral dose 2 |
NNC0487-0111 oral dose 2 treatment |
|
|
Experimental NNC0487-0111 oral dose 3 |
NNC0487-0111 oral dose 3 treatment |
|
Recruiting Locations
Medstar Research Institute_Hyattsville
Hyattsville, Maryland 20782
Hyattsville, Maryland 20782
More Details
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S