Clinical trial NCT03766854: A Research Study of How Different Amounts of a New Medicine NNC0148-0287 C (Insulin 287) Works on the Blood Sugar of People Who Are Japanese With Type 1 Diabetes When Given Once a Week
Official title: A Multiple-dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Japanese Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will look at how insulin 287 works, if it is safe and the side effects in people who are Japanese with type 1 diabetes. The study will test how insulin goes through your blood, how long it stays there and how the blood sugar is lowered. Insulin 287 is a new medicine. Insulin glargine is already approved to treat diabetes. The study doctors can prescribe insulin glargine. The participants will get both of the insulins in a random order. The participants 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 7 weeks when the participants inject insulin glargine every day before they start insulin 287 period or insulin glargine period. All doses will be injected under the skin. During the run-in period, the participants adjust the insulin glargine dose and make their blood sugar levels stable. From the run-in period, the participants will take insulin aspart as bolus insulin. The study will last for about 16 - 28 weeks. The participants will have 24 visits with the study doctor. There will be 3 glucose clamps where the participants' blood sugar is tested over time. The participants cannot be in the study if the study doctor thinks that there are risks for their health.


Eligibility criteria: Inclusion Criteria:

* Male or female, Japanese subjects, aged 20 - 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 28.0 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 (except conditions associated with diabetes mellitus).
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
* Known or suspected hypersensitivity to trial products or related products

Primary outcomes:
measure: AUCI287τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state
timeFrame: From 0 to 168 hours after trial product administration (day 50)
Secondary outcomes:
measure: Number of adverse events (AEs)
timeFrame: From first trial product administration (day 1) to end of last dosing interval (day 57 for insulin 287, day 15 for IGlar)
measure: Number of hypoglycaemic episodes
timeFrame: From first trial product administration (day 1) to end of last dosing interval (day 57 for insulin 287, day 15 for IGlar) excluding clamp days
measure: Change in antiinsulin 287 antibody level
timeFrame: From first insulin 287 administration (day 1) to follow-up visit (day 106)
measure: Change in antiinsulin 287 antibody titres
timeFrame: From first insulin 287 administration (day 1) to follow-up visit (day 106)
measure: Positive cross-reactive anti-human insulin antibodies
timeFrame: At follow-up visit (day 106)
measure: AUCI287,0-168,FD - Area under the serum insulin 287 concentration-time curve after the first dose
timeFrame: From 0 to 168 hours after trial product administration (day 1)
measure: tmax,I287,FD - Time to maximum observed serum insulin 287 concentration after the first dose
timeFrame: From 0 to 168 hours after trial product administration (day 1)
measure: Cmax,I287,FD - Maximum observed serum insulin 287 concentration after the first dose
timeFrame: From 0 to 168 hours after trial product administration (day 1)
measure: tmax,I287,SS - Time to maximum observed serum insulin 287 concentration after the last dose
timeFrame: From 0 to 168 hours after trial product administration (day 50)
measure: Cmax,I287,SS - Maximum observed serum insulin 287 concentration after the last dose
timeFrame: From 0 to 168 hours after trial product administration (day 50)
measure: t1/2,I287,SS - Terminal half-life for insulin 287 at steady state
timeFrame: 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)
measure: CI287,trough - Serum insulin 287 trough concentration
timeFrame: Measured at the end of each dosing interval 168 hours after dosing (day 8, 15, 22, 29, 36, 43, 50 and 57)
measure: AUCIGlar,τ,SS - Area under the serum IGlar concentration-time curve during one dosing interval at steady state
timeFrame: From 0 to 24 hours after trial product administration (day 14)
measure: Cmax,IGlar,SS - Maximum observed serum IGlar concentration at steady state
timeFrame: From 0 to 24 hours after trial product administration (day 14)
measure: tmax,IGlar,SS - Time to maximum observed serum IGlar concentration at steady state
timeFrame: From 0 to 24 hours from trial product administration (day 14)
measure: CIGlar,trough - Serum IGlar trough concentration
timeFrame: Measured at the end of each dosing interval 24 hours after trial product administration (day 7, 14 and 15)
measure: AUCGIR,24-48h,SS - Area under the glucose infusion rate-time curve at steady state
timeFrame: From 24 to 48 hours after trial product administration (day 51)
measure: GIRmax,24-48h, SS - Maximum observed glucose infusion rate at steady state
timeFrame: From 24 to 48 hours after trial product administration (day 51)
measure: AUCGIR,150-168h,SS - Area under the glucose infusion rate-time curve at steady state
timeFrame: From 150 to 168 hours after trial product administration (day 57)
measure: GIRmax,150-168h,SS - Maximum observed glucose infusion rate at steady state
timeFrame: From 150 to 168 hours after trial product administration (day 57)
measure: AUCGIR,0-24h,SS - Area under the glucose infusion rate-time curve at steady state
timeFrame: From 0 to 24 hours after trial product administration (day 14)
measure: GIRmax,0-24h,SS - Maximum observed glucose infusion rate at steady state
timeFrame: From 0 to 24 hours after trial product administration (day 14)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: