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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

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

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo subcutaneous 		Placebo for subcutaneous treatment
  • Drug: Placebo (NNC0487-0111 subcutanous)
    NNC0487-0111 placebo administered subcutanously (under the skin)
Experimental
NNC0487-0111 subcutaneous dose 1 		NNC0487-0111 subcutaneous dose 1 treatment
  • Drug: NNC0487-0111 subcutanous
    NNC0487-0111 administered subcutanously (under the skin)
Experimental
NNC0487-0111 subcutaneous dose 2 		NNC0487-0111 subcutaneous dose 2 treatment
  • Drug: NNC0487-0111 subcutanous
    NNC0487-0111 administered subcutanously (under the skin)
Experimental
NNC0487-0111 subcutaneous dose 3 		NNC0487-0111 subcutaneous dose 3 treatment
  • Drug: NNC0487-0111 subcutanous
    NNC0487-0111 administered subcutanously (under the skin)
Experimental
NNC0487-0111 subcutaneous dose 4 		NNC0487-0111 subcutaneous dose 4 treatment
  • Drug: NNC0487-0111 subcutanous
    NNC0487-0111 administered subcutanously (under the skin)
Experimental
NNC0487-0111 subcutaneous dose 5 		NNC0487-0111 subcutaneous dose 5 treatment
  • Drug: NNC0487-0111 subcutanous
    NNC0487-0111 administered subcutanously (under the skin)
Experimental
NNC0487-0111 subcutaneous dose 6 		NNC0487-0111 subcutaneous dose 6 treatment
  • Drug: NNC0487-0111 subcutanous
    NNC0487-0111 administered subcutanously (under the skin)
Placebo Comparator
Placebo oral 		Placebo for oral treatment
  • Drug: Placebo (NNC0487-0111 oral)
    NNC0487-0111 placebo administered orally (in the mouth)
Experimental
NNC0487-0111 oral dose 1 		NNC0487-0111 oral dose 1 treatment
  • Drug: NNC0487-0111 oral
    NNC0487-0111 administered orally (in the mouth)
Experimental
NNC0487-0111 oral dose 2 		NNC0487-0111 oral dose 2 treatment
  • Drug: NNC0487-0111 oral
    NNC0487-0111 administered orally (in the mouth)
Experimental
NNC0487-0111 oral dose 3 		NNC0487-0111 oral dose 3 treatment
  • Drug: NNC0487-0111 oral
    NNC0487-0111 administered orally (in the mouth)

Recruiting Locations

Medstar Research Institute_Hyattsville
Hyattsville, Maryland 20782

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.