Diabetes Mellitus, Type 1
Conditions
Brief summary
This study compares the new long-acting insulin 287 with the marketed insulin glargine for use in type 1 diabetes. The study will test how insulin is taken up in your blood, how long it stays there and how the blood sugar is lowered. The participant will get both of the insulins in a random order. Insulin 287 is a new medicine while insulin glargine is already approved for the treatment of diabetes and can be prescribed by a doctor. The participant will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. There will also be a run-in period of 2 days to 4 weeks with daily doses of insulin glargine before you start the insulin 287 period. All doses will be injected under the skin. The study will last for about 16 to 24 weeks. The participant will have 27 visits with the study doctor.
Interventions
DRUGInsulin icodec
Participants will receive subcutaneous injections of insulin 287 once weekly for 8 weeks
DRUGIGlar U100
Participants will receive subcutaneous injections of insulin glargine once weekly for 2 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent * Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening * Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day * Body mass index between 18.5 and 29.0 kg/m\^2 (both inclusive) * HbA1c less than or equal to 9.0%
Exclusion criteria
* History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions. Subjects with complications associated to diabetes can be included only if they are judged to be mild by the investigator. Subjects with other comorbidities (e.g. dyslipidaemia, hypertension and hypothyroidism) can be included if they have a stable treatment and are in adequate control according to the judgement of the investigator- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) * Known or suspected hypersensitivity to trial products or related products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCI287,τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state | From 0 to 168 hours after trial product administration (Day 50) | Measured in pmol\*h/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state | From 138 to 168 hours after trial product administration (Day 50) | Measured in mg/kg |
| GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state | From 16 to 52 hours after trial product administration (Day 50) | Measured in mg/(kg\*min) |
| GIRmax,138-168h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state | From 138 to 168 hours after trial product administration (Day 50) | Measured in mg/(kg\*min) |
| AUCGIR,0-24h,SS (for insulin glargine) - Area under the glucose infusion rate-time curve at steady state | From 0 to 24 hours after trial product administration (Day 14) | Measured in mg/kg |
| GIRmax,0-24h, SS (for insulin glargine) - Maximum observed glucose infusion rate at steady state | From 0 to 24 hours after trial product administration (Day 14) | Measured in mg/(kg\*min) |
| AUCI287,0-168h,FD (from insulin 287) - Area under the serum insulin 287 concentration-time curve after the first dose | From 0 to 168 hours after trial product administration (Day 1) | Measured in pmol\*h/L |
| Cmax,I287,FD (for insulin 287) - Maximum observed serum insulin 287 concentration after the first dose | From 0 to 168 hours after trial product administration (Day 1) | Measured in pmol/L |
| tmax,I287,FD (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the first dose | From 0 to 168 hours after trial product administration (Day 1) | Measured in hours |
| Cmax,I287,SS (for insulin 287) - Maximum observed serum insulin 287 concentration after the last dose | From 0 to 168 hours after trial product administration (Day 50) | Measured in pmol/L |
| tmax,I287,SS (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the last dose | From 0 to 168 hours after trial product administration (Day 50) | Measured in hours |
| AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state | From 16 to 52 hours after trial product administration (Day 50) | Measured in mg/kg |
| CI287,trough (for insulin 287) - Serum insulin 287 trough concentration | Measured at the end of each dosing interval 168 hours after trial product administration (Day 8, 15, 22, 29, 36, 43, 50 and 57) | Measured in pmol/L |
| AUCIGlar,τ,SS (for insulin glargine) - Area under the serum insulin glargine concentration-time curve during one dosing interval at steady state | From 0 to 24 hours after trial product administration (Day 14) | Measured in pmol\*h/L |
| Cmax,IGlar,SS (for insulin glargine) - Maximum observed serum insulin glargine concentration at steady state | From 0 to 24 hours after trial product administration (Day 14) | Measured in pmol/L |
| tmax,IGlar,SS (for insulin glargine) - Time to maximum observed serum insulin glargine concentration at steady state | From 0 to 24 hours after trial product administration (Day 14) | Measured in hours |
| CIGlar,trough (for insulin glargine) - Serum insulin glargine trough concentration | Measured at the end of each dosing interval 24 hours after trial product administration (Day 4, 7, 14 and 15) | Measured in pmol/L |
| Number of adverse events (AEs) | From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar) | Number of events |
| Number of hypoglycaemic episodes | From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar) | Number of episodes |
| Change in anti-insulin 287 antibody level | From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106) | Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer) |
| Change in anti-insulin 287 antibody titres | From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106) | Number of dilutions |
| Positive cross-reactive anti-human insulin antibodies | At the follow-up visit (Visit 25, day 106) | Number of patients with/without positive cross-reactive anti-human insulin antibodies |
| t½,I287,SS (for insulin 287) - Terminal half-life for insulin 287 at steady state | Terminal part of the serum insulin 287 concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 50) | Measured in hours |
Countries
Germany
Outcome results
None listed