Diabetes Mellitus, Type 2
Conditions
Brief summary
Novo Nordisk is developing a combination therapy with the study medicine NNC0480-0389 and an already approved medicine called semaglutide for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone.In this study the blood levels of NNC0480-0389 will be compared in people with various degrees of reduced kidney function to the blood levels in people with normal kidney function, after administration of one dose of 18 mg NNC0480-0389. Participants will only get the study medicine as two injections into a skinfold of participants belly (subcutaneous). The study will last for about 65 days including a screening phase of up to 28 days prior to dosing. If participants are eligible for the study, participants will have 11 visits to the study centre including one in-house stay of 5 days and 4 nights (Visit 2) and nine ambulatory visits (Visit 3 to Visit 11). Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood drawn, urine will be collected and electrocardiograms (ECGs) will be recorded.If participants are women and can get pregnant they cannot take part in the study. A hormone test will be done to check if participants may be post-menopausal.
Interventions
DRUGNNC0480-0389
A single dose of 18 mg NNC0480 0389 administered subcutaneously (under the skin). Total duration of study participation for each participant is 38 to 66 days
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 informed consent. * Body mass index (BMI) between 20.0 and 39.9 kg/m\^2 (both inclusive) * Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups: * For participants with normal renal function: eGFR of equal to or greater than 90 mL/min * For participants with mild renal impairment: eGFR of 60-89 mL/min * For participants with moderate renal impairment: eGFR of 30-59 mL/min * For participants with severe renal impairment: eGFR of 15-29 mL/min not requiring dialysis * For participants with kidney failure: eGFR of less than 15 mL/min or requiring dialysis treatment Specific inclusion criteria for participants with kidney failure requiring dialysis treatment: \* Current treatment with haemodialysis
Exclusion criteria
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening. * Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim and cibenzoline within 14 days or 5 half-lives, whichever is greater, before dosing the investigational medicinal product (IMP). * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞,NNC0480-0389,SD, area under the NNC0480-0389 plasma concentration time curve after a single dose | From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36) | h\*nmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,NNC0480-0389,SD, Maximum observed NNC0480-0389 plasma concentration after a single dose | From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36) | nmol/L |
Countries
Germany
Outcome results
None listed