Diabetes, Type 2 Diabetes Mellitus
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes
Interventions
DRUGInsulin icodec
Administered once-weekly subcutaneously (s.c., under the skin) for 35 days
DRUGinsulin degludec
Administered once-daily subcutaneously (s.c., under the skin) for 35 days
DRUGplacebo
Administered subcutaneously (s.c., under the skin) once-daily for 35 days
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent * Females of no childbearing potential \[if surgically sterilized (i.e. tubal ligation, bilateral oophorectomises or hysterectomised) for at least 3 months or if post-menopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by FSH (follicle-stimulating hormone) levels above 40 U/L\] * Body mass index (BMI) between 20.0 and 35.0 kg/m\^2 (both inclusive) * Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
Exclusion criteria
* Known or suspected hypersensitivity to trial products or related products * Receipt of any investigational medicinal products within 3 months before screening * Use of oral antidiabetic drugs (OADs) or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events | From the first trial product administration at Day 1 until completion of the post-treatment follow-up visit (3-14 days after Visit 9, Day 65) |
Secondary
| Measure | Time frame |
|---|---|
| Area under the steady-state serum insulin 287 concentration-time curve | During one dosing interval at steady-state from 0 to 168 h after last dose (Day 29) |
| area under the glucose infusion rate - time curve at steady-state | At Day 31 and day 35 |
Countries
Germany
Outcome results
None listed