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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
EU CTIS ID: 2023-509412-28-00
What this study is testing
To demonstrate and characterise the dose response relationship of QW s.c. NNC0487-0111, and to compare the effect of varying doses to placebo, for change in HbA1c from baseline to week 36 in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor. To demonstrate and characterise the dose response relationship of QD oral NNC0487-0111, and to compare the effect of varying doses to placebo, for change in HbA1c from baseline to week 36 in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- Stable daily dose(s) ≥ 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% (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
- Body mass index between ≥ 23.0 and <50.0 kg/m2.
- 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.
You likely can't join if
- 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 question4.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.