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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin Icodec

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin icodec; Participants will receive individualised weekly doses of insulin icodec	Drug: Insulin Icodec; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state	pmol*h/L	From 0 to 168 hours after trial product administration (Day 50)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCGIR,0-36h,SS,Area under the glucose infusion rate-time curve at steady state	mg/kg	From 0 to 36 hours after trial product administration (Day 36)
AUCGIR,40-64h,SS,Area under the glucose infusion rate-time curve at steady state	mg/kg	From 40 to 64 hours after trial product administration (Day 43)
AUCGIR,144-168h,SS,Area under the glucose infusion rate-time curve at steady state	mg/kg	From 144 to 168 hours after trial product administration (Day 50)
AUCGIR,τ,SS,model, Model-based area under the glucose infusion rate-time curve during one dosing interval at steady state	mg/kg	From 0 to 168 hours after trial product administration (Day 50)
AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state	pmol*h/L	From 0 to 168 hours after trial product administration (Day 36 and 43)
Dose-normalised AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose	(pmol*h/L)/(U/kg)	From 0 to 168 hours after trial product administration (Day 50)
Cmax,Ico,SS, Maximum observed serum insulin icodec concentration during one dosing interval at steady state	pmol/L	From 0 to 168 hours after trial product administration (Day 36, 43 and 50)
Dose-normalised Cmax,Ico,SS, Maximum observed serum insulin icodec concentration after the last dose divided by dose	(pmol/L)/(U/kg)	From 0 to 168 hours after trial product administration (Day 50)
tmax,Ico,SS, Time to maximum observed serum insulin icodec concentration after the last dose	hours	From 0 to 168 hours after trial product administration (Day 50)
t½,Ico,SS, Terminal half-life for insulin icodec at steady state	hours	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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Publications and helpful links

General Publications

• 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 Sep 11. doi: 10.1111/dom.15266. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): April 22, 2022
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: NN1436-4569; U1111-1244-4346 (Other Identifier: World Health Organization (WHO)); 2019-004606-10 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No