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NCT Number: NCT04582448

A Study Looking at How Insulin Icodec is Taken up in the Blood When Administered in Different Injection Sites in People With Type 2 Diabetes

This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions.

Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh.

The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak.

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

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Key information

Conditions

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

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Mainz, 55116, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female
  • Aged 18-69 years (both inclusive) at the time of signing informed consent
  • Body mass index between 18.5 and 38.0 kg/m^2 (both inclusive)
  • Diagnosed with type 2 diabetes mellitus above or equal to 180 days prior to the day of screening
  • HbA1c (glycated haemoglobin) below or equal to 9.0 percentage at screening
  • Current daily basal insulin treatment of 0.2-1.0 (I)U/kg/day (both inclusive) with or without any of the following anti-diabetic drugs/regimens with stable doses above or equal to 90 days prior to the day of screening:
  • Any metformin formulation
  • Other oral antidiabetic drugs: DPP-4 inhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
  • Oral or injectable GLP-1 (glucagon-like peptide 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 (adequate contraceptive measures as required by local regulation or practice).

Treatment and study plan

Insulin icodec

Drug

A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.

Primary outcomes

  1. AUCIco,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose

    Time frame: Day 1

    From 0 hours until infinity after trial product administration (pmol*h/L)

Secondary outcomes

  1. Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose

    Time frame: Day 1

    From 0 hours until infinity after trial product administration (pmol/L)

  2. tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose

    Time frame: Day 1

    From 0 hours until infinity after trial product administration (hours)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec After Administration in Different Injection Regions in Subjects With Type 2 Diabetes

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2020
Registry last updated
Jan 20, 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.

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