Diabetes Mellitus, Type 2
Conditions
Brief summary
NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing.
Interventions
DRUGNNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 20.0 and 39.9 kilogram per square metre (kg/m\^2) (both inclusive) at screening. * Meeting the pre-defined glomerular filtration rate (GFR) criteria using estimated GFR (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI) Creatinine Equation (2021) adjusted for estimated individual body surface area (BSA) for any of the renal function groups: * For participants with normal renal function: eGFR of greater than or equal to 90 millilitres per minute (mL/min) * Stage 2: For participants with mild renal impairment: eGFR of 60-89 mL/min * Stage 3: For participants with moderate renal impairment: eGFR of 30-59 mL/min * Stage 4: For participants with severe renal impairment: eGFR of 15-29 mL/min not requiring dialysis * Stage 5: For participants with kidney failure: eGFR of less than 15 mL/min and requiring dialysis treatment
Exclusion criteria
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or kidney failure) as judged by the investigator. * Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment | From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22) | Measured in hours\* nanomoles per litre (h\*nmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment | From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22) | Measured in nanomoles per litre (nmol/L). |
| AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure | From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22) | Measured in hours\* nanomoles per litre (h\*nmol/L). |
| Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure | From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22) | Measured in nanomoles per litre (nmol/L). |
| Number of adverse events | From time of dosing (visit 2, day 1) until end of study (visit 9, day 22) | Number of events. |
Countries
Germany
Outcome results
None listed