Skip to main content
OpenTrials
Completed

NCT Number: NCT04582435

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin icodec

Drug

Participants will receive 1 dose from a prefilled pen, administered subcutaneously (under the skin), once a week by designated study staff, for a total of at least 8 and a maximum of 16 doses which equals 8-16 weeks of treatment.

Primary outcomes

  1. AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state

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

    pmol*h/L

Secondary outcomes

  1. AUCGIR,0-36h,SS,Area under the glucose infusion rate-time curve at steady state

    Time frame: From 0 to 36 hours after trial product administration (Day 36)

    mg/kg

  2. AUCGIR,40-64h,SS,Area under the glucose infusion rate-time curve at steady state

    Time frame: From 40 to 64 hours after trial product administration (Day 43)

    mg/kg

  3. AUCGIR,144-168h,SS,Area under the glucose infusion rate-time curve at steady state

    Time frame: From 144 to 168 hours after trial product administration (Day 50)

    mg/kg

  4. AUCGIR,τ,SS,model, Model-based area under the glucose infusion rate-time curve during one dosing interval at steady state

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

    mg/kg

  5. AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state

    Time frame: From 0 to 168 hours after trial product administration (Day 36 and 43)

    pmol*h/L

  6. Dose-normalised AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose

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

    (pmol*h/L)/(U/kg)

  7. Cmax,Ico,SS, Maximum observed serum insulin icodec concentration during one dosing interval at steady state

    Time frame: From 0 to 168 hours after trial product administration (Day 36, 43 and 50)

    pmol/L

  8. Dose-normalised Cmax,Ico,SS, Maximum observed serum insulin icodec concentration after the last dose divided by dose

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

    (pmol/L)/(U/kg)

  9. tmax,Ico,SS, Time to maximum observed serum insulin icodec concentration after the last dose

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

    hours

  10. t½,Ico,SS, Terminal half-life for insulin icodec at steady state

    Time frame: 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)

    hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.