Clinical trial NCT04582435: A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes
Official title: A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-10-09
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to improve clinical outcomes for patients with type 2 diabetes by limiting the burden associated with insulin treatment.

Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors.

Participants will administer subcutaneous injections of insulin degludec once daily for at least one week (7 injections) but this period may be extended up to 8 weeks. Thereafter, once weekly subcutaneous injections of insulin icodec will follow, resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec.

The study will last for about 17-32 weeks Participants will have at least 5 in-house visits (where participants will stay at the clinic) and 17 outpatient visits with the study doctor.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged 18-75 years (both inclusive) at the time of signing informed consent
* Body mass index between 18.0 and 38.0 kg/m\^2 (both inclusive)
* HbA1c (glycated haemoglobin) below or equal to 9 percentage (75 mmol/mol) at screening
* Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to the day of screening: 1) Any metformin formulation 2) Other oral antidiabetic drugs: DPP-4 nhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
* Oral or injectable GLP-1 Receptor Agonists

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method

Primary outcomes:
measure: AUCIco,τ,SS, Area under the serum insulin icodec 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: AUCGIR,0-36h,SS,Area under the glucose infusion rate-time curve at steady state
timeFrame: From 0 to 36 hours after trial product administration (Day 36)
measure: AUCGIR,40-64h,SS,Area under the glucose infusion rate-time curve at steady state
timeFrame: From 40 to 64 hours after trial product administration (Day 43)
measure: AUCGIR,144-168h,SS,Area under the glucose infusion rate-time curve at steady state
timeFrame: From 144 to 168 hours after trial product administration (Day 50)
measure: AUCGIR,τ,SS,model, Model-based area under the glucose infusion rate-time curve during one dosing interval at steady state
timeFrame: From 0 to 168 hours after trial product administration (Day 50)
measure: AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state
timeFrame: From 0 to 168 hours after trial product administration (Day 36 and 43)
measure: Dose-normalised AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose
timeFrame: From 0 to 168 hours after trial product administration (Day 50)
measure: Cmax,Ico,SS, Maximum observed serum insulin icodec concentration during one dosing interval at steady state
timeFrame: From 0 to 168 hours after trial product administration (Day 36, 43 and 50)
measure: Dose-normalised Cmax,Ico,SS, Maximum observed serum insulin icodec concentration after the last dose divided by dose
timeFrame: From 0 to 168 hours after trial product administration (Day 50)
measure: tmax,Ico,SS, Time to maximum observed serum insulin icodec concentration after the last dose
timeFrame: From 0 to 168 hours after trial product administration (Day 50)
measure: t½,Ico,SS, Terminal half-life for insulin icodec at steady state
timeFrame: Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 50)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References:
citation: Pieber TR, Asong M, Fluhr G, Holler V, Kristensen NR, Larsen JH, Ribel-Madsen R, Svehlikova E, Vinther S, Voortman M, Haahr H. Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 2 diabetes. Diabetes Obes Metab. 2023 Dec;25(12):3716-3723. doi: 10.1111/dom.15266. Epub 2023 Sep 11.