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A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

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Status and phase

Enrolling
Phase 2

Conditions

Type 2 Diabetes (T2D)

Treatments

Drug: Placebo (NNC0487-0111 oral)
Drug: NNC0487-0111 oral
Drug: NNC0487-0111 subcutanous
Drug: Placebo (NNC0487-0111 subcutanous)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06542874
U1111-1296-9708 (Other Identifier)
NN9490-7678
2023-509412-28 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

432 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

432 participants in 11 patient groups, including a placebo group

Placebo subcutaneous
Placebo Comparator group
Description:
Placebo for subcutaneous treatment
Treatment:
Drug: Placebo (NNC0487-0111 subcutanous)
NNC0487-0111 subcutaneous dose 1
Experimental group
Description:
NNC0487-0111 subcutaneous dose 1 treatment
Treatment:
Drug: NNC0487-0111 subcutanous
NNC0487-0111 subcutaneous dose 2
Experimental group
Description:
NNC0487-0111 subcutaneous dose 2 treatment
Treatment:
Drug: NNC0487-0111 subcutanous
NNC0487-0111 subcutaneous dose 3
Experimental group
Description:
NNC0487-0111 subcutaneous dose 3 treatment
Treatment:
Drug: NNC0487-0111 subcutanous
NNC0487-0111 subcutaneous dose 4
Experimental group
Description:
NNC0487-0111 subcutaneous dose 4 treatment
Treatment:
Drug: NNC0487-0111 subcutanous
NNC0487-0111 subcutaneous dose 5
Experimental group
Description:
NNC0487-0111 subcutaneous dose 5 treatment
Treatment:
Drug: NNC0487-0111 subcutanous
NNC0487-0111 subcutaneous dose 6
Experimental group
Description:
NNC0487-0111 subcutaneous dose 6 treatment
Treatment:
Drug: NNC0487-0111 subcutanous
Placebo oral
Placebo Comparator group
Description:
Placebo for oral treatment
Treatment:
Drug: Placebo (NNC0487-0111 oral)
NNC0487-0111 oral dose 1
Experimental group
Description:
NNC0487-0111 oral dose 1 treatment
Treatment:
Drug: NNC0487-0111 oral
NNC0487-0111 oral dose 2
Experimental group
Description:
NNC0487-0111 oral dose 2 treatment
Treatment:
Drug: NNC0487-0111 oral
NNC0487-0111 oral dose 3
Experimental group
Description:
NNC0487-0111 oral dose 3 treatment
Treatment:
Drug: NNC0487-0111 oral

Trial contacts and locations

94

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Central trial contact

Novo Nordisk

Data sourced from clinicaltrials.gov

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