A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week

Novo Nordisk A/S66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

AUCI287,τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state

Measured in pmol\*h/L

Time frame: From 0 to 168 hours after trial product administration (Day 50)

Secondary Outcomes

AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state

Measured in mg/kg

Time frame: From 16 to 52 hours after trial product administration (Day 50)

AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state

Measured in mg/kg

Time frame: From 138 to 168 hours after trial product administration (Day 50)

GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state

Measured in mg/(kg\*min)

Time frame: From 16 to 52 hours after trial product administration (Day 50)

GIRmax,138-168h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state

Measured in mg/(kg\*min)

Time frame: From 138 to 168 hours after trial product administration (Day 50)

AUCGIR,0-24h,SS (for insulin glargine) - Area under the glucose infusion rate-time curve at steady state

Measured in mg/kg

Time frame: From 0 to 24 hours after trial product administration (Day 14)

GIRmax,0-24h, SS (for insulin glargine) - Maximum observed glucose infusion rate at steady state

Measured in mg/(kg\*min)

Time frame: From 0 to 24 hours after trial product administration (Day 14)

AUCI287,0-168h,FD (from insulin 287) - Area under the serum insulin 287 concentration-time curve after the first dose

Measured in pmol\*h/L

Time frame: From 0 to 168 hours after trial product administration (Day 1)

Cmax,I287,FD (for insulin 287) - Maximum observed serum insulin 287 concentration after the first dose

Measured in pmol/L

Time frame: From 0 to 168 hours after trial product administration (Day 1)

tmax,I287,FD (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the first dose

Measured in hours

Time frame: From 0 to 168 hours after trial product administration (Day 1)

Cmax,I287,SS (for insulin 287) - Maximum observed serum insulin 287 concentration after the last dose

Measured in pmol/L

Time frame: From 0 to 168 hours after trial product administration (Day 50)

tmax,I287,SS (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the last dose

Measured in hours

Time frame: From 0 to 168 hours after trial product administration (Day 50)

t½,I287,SS (for insulin 287) - Terminal half-life for insulin 287 at steady state

Measured in hours

Time frame: 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)

CI287,trough (for insulin 287) - Serum insulin 287 trough concentration

Measured in pmol/L

Time frame: Measured at the end of each dosing interval 168 hours after trial product administration (Day 8, 15, 22, 29, 36, 43, 50 and 57)

AUCIGlar,τ,SS (for insulin glargine) - Area under the serum insulin glargine concentration-time curve during one dosing interval at steady state

Measured in pmol\*h/L

Time frame: From 0 to 24 hours after trial product administration (Day 14)

Cmax,IGlar,SS (for insulin glargine) - Maximum observed serum insulin glargine concentration at steady state

Measured in pmol/L

Time frame: From 0 to 24 hours after trial product administration (Day 14)

tmax,IGlar,SS (for insulin glargine) - Time to maximum observed serum insulin glargine concentration at steady state

Measured in hours

Time frame: From 0 to 24 hours after trial product administration (Day 14)

CIGlar,trough (for insulin glargine) - Serum insulin glargine trough concentration

Measured in pmol/L

Time frame: Measured at the end of each dosing interval 24 hours after trial product administration (Day 4, 7, 14 and 15)

Number of adverse events (AEs)

Number of events

Time frame: From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar)

Number of hypoglycaemic episodes

Number of episodes

Time frame: From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar)

Change in anti-insulin 287 antibody level

Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer)

Time frame: From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106)

Change in anti-insulin 287 antibody titres

Number of dilutions

Time frame: From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106)

Positive cross-reactive anti-human insulin antibodies

Number of patients with/without positive cross-reactive anti-human insulin antibodies

Time frame: At the follow-up visit (Visit 25, day 106)

A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes